Opportunities

Challenges motivate us and collaboration facilitates our success. We are energized by the fast-paced environment of medtech innovation. We commit to delivering client
results and fostering professional development.

History

Mike and Darlene established Experien Group to address resource challenges they faced as senior executives in the medical device industry. They recognized that companies large and small need a cohesive team of experts to hit meaningful milestones. With measured growth, they have personally selected and developed a group of professionals who share their mission and demonstrate significant value for our clients.

Culture

Our work is serious but our team brings passion and fun to the process. Mike and Darlene have maintained a family dynamic since the firm’s beginning and our staff genuinely value one another. Experien = Excellence, Experience, Expertise and Entrepreneurship. Group = Community, Collaboration, Contribution and Engagement.

Future

Business models and regulatory challenges modulate over time. We evolve with the industry, supporting traditional device companies as well as newer entrants to the marketplace. We maintain a full-service firm with the breadth and depth to help companies commercialize wide-ranging, clinically impactful technologies.

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Mentorship

Our team is continually learning; we evolve together. With a hands-on culture combining junior and senior resources, we deliver efficient and superior results for our clients and professional development opportunities for our staff. We are current to the latest industry requirements and strive always to be best-in-class.

Openings

Our firm’s strength comes from its people. We seek motivated, engaging professionals who enjoy a fast-paced, collaborative environment. We roll up our sleeves to work alongside our clients and look for applicants who thrive under this approach. We welcome serious inquiries about joining Experien Group.

Current openings
Quality Specialist

We are seeking a Quality Specialist to support our Quality Team.

Quality Specialist

We are a dynamic group of professionals providing regulatory, quality and clinical services for the medical device industry. Our team supports start-ups, mid-sized private companies and large corporations at all stages of the product life cycle. We work across a broad spectrum of technologies and treatment modalities; our clients develop both next generation and paradigm shifting devices. Our product exposure includes implantables, instruments (manual, laser, robotic, etc.), capital equipment, combination products, software as a medical device (SaMD), medical apps, in vitro diagnostics and more.
We are seeking a Quality Specialist to support our Quality Team. The Quality Specialist is responsible for managing the release, maintenance, retrieval, disposition and retention of controlled documents in support of medical device manufacturing and operations for multiple clients. This position will report to the Quality Manager of Experien Group.

MAJOR DUTIES OF POSITION:

  • Generates and processes document change orders to release documents (e.g., Standard Operating Procedures, forms, components, part numbers, etc.) into each client’s Quality Management System
  • Maintains clients’ controlled document files to ensure only current released documents are available for use
  • Maintains the control of records including CAPAs, NCMRs, Design Control, Risk Management files, etc.
  • Assists in updating clients’ Standard Operating Procedures and other Quality Management System procedures
  • Manages clients’ training activities including sending out training notifications and maintaining individuals’ training records
  • Assists in implementing and maintaining clients’ Electronic Document Management Systems, as applicable
  • Scanning, filing and maintenance of all types of Quality System documents and records
  • Maintain Document Control and Quality System-related document retention, databases and logs
  • Assist with other Quality System related duties, as assigned

KNOWLEDGE AND SKILL REQUIREMENTS:

  • College degree preferred
  • Minimum of two years experience with Document Control in a regulated environment
  • Proficient in Microsoft Word, Excel, Power Point and Adobe Acrobat
  • Must be able to work independently with minimal supervision
  • Must be organized and have strong attention to detail
  • Excellent communication and time management skills required
  • Ability to learn quickly and prioritize multiple tasks in a fast paced and dynamic environment
  • Ability to work on multiple projects for multiple clients at the same time
  • Knowledge of ISO 13485:2016 and 21 CFR 820 requirements preferred
  • Knowledge of Electronic Document Management Systems preferred

BENEFITS:

  • Medical, Dental and Vision Benefits
  • 18 Days of Paid Time-Off (PTO)
  • 11 Paid Holidays
  • 401(k)

The above description is intended to describe the general content, identify the essential functions of, and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or requirements.

Please send your resume.
Quality Engineer I/II/Sr.

We are seeking a Quality Engineer to support our senior Quality team.

Quality Engineer I/II/Sr.

We are a dynamic group of professionals providing regulatory, quality and clinical services for the medical device industry. Our team supports start-ups, mid-sized private companies and large corporations at all stages of the product life cycle. We work across a broad spectrum of technologies and treatment modalities; our clients develop both next generation and paradigm shifting devices. Our product exposure includes implantables, instruments (manual, laser, robotic, etc.), capital equipment, combination products, software as a medical device (SaMD), medical apps, in vitro diagnostics and more.

We are seeking a Quality Engineer to support our senior Quality team. The Quality Engineer will organize and manage the Quality activities for companies to help them identify and meet their Quality Management System needs. Additionally, the Quality Engineer will evaluate design outputs for quality requirements and establish quality, risk, or other management plans for equipment and processes for general and specific product performance needs. These activities must be in accordance with industry standards testing, FDA Quality System Regulation, ISO 13485, ISO 14971, the EU Medical Device Directive and the EU Medical Devices Regulation.

MAJOR DUTIES OF POSITION:

  • Perform device design control and quality engineering activities. This will include working with outside clients to complete design control activities.
  • Support cross-functional teams in developing and executing Verification and Validation Plans, including writing and executing related protocols and reports.
  • Provide Risk Management expertise in the evaluation and design of product, design validation and verification, complaint and nonconforming materials investigations and implementation of corrective and preventive action (CAPA), as required.
  • Hold responsibility for applying appropriate design controls, manufacturing controls, quality assurance techniques and controls, and statistical controls and methodology throughout the life cycle for respective products.
  • Maintain accountability for project timelines and deliverables to both internal and external management.
  • Facilitate the documentation of risk management using industry standard tools including FMEAs and Fault Tree Analysis for systems, subsystems, manufacturing processes and clinical workflows to ISO 14971.
  • Drive risk mitigation, including verification of risk mitigations, through design and product requirement definitions.
  • Ensure completion and documentation of verification and validation activities, including traceability to requirements in compliance with applicable quality system regulations.
  • Provide input and/or oversight for other quality system related activities, including complaint handling, CAPA investigation and supplier evaluations, as needed to assist clients in ensuring product quality and proper implementation of compliant processes.

KNOWLEDGE AND SKILL REQUIREMENTS:

  • Bachelor degree in Engineering or Life Sciences required, master’s degree preferred.
  • Minimum 2 years experience preferred for Quality Engineer I/II
  • Minimum of 4 years of medical device industry experience required for Senior Quality Engineer
  • High attention to detail and project management skills a must.
  • Knowledge of medical device regulations and standards (i.e., QSR, ISO 13485, ISO 14971, ISO 60601 series, ISO 62304, ISO 10993 series, ISO 11135, and ISO 11137) required.
  • Experience in a full product life cycle, including definition of customer needs, development, design testing, design transfer, manufacturing scale up, distribution, service and post market analysis is critical.
  • Sound understanding of concepts and principles of Quality Assurance with respect to new product development, regulatory bodies, external suppliers, product manufacturing and product servicing is necessary.
  • Excellent verbal and writing skills are required.

BENEFITS:

  • Medical, Dental and Vision Benefits
  • 18 Days of Paid Time-Off (PTO)
  • 11 Paid Holidays
  • 401(k)

The above description is intended to describe the general content, identify the essential functions of, and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or requirements.

Please send your resume.
Software Quality Engineer I/II/Sr.

We are seeking a Software Quality Engineer to support our senior Quality team.

Software Quality Engineer I/II/Sr.

We are a dynamic group of professionals providing regulatory, quality and clinical services for the medical device industry. Our team supports start-ups, mid-sized private companies and large corporations at all stages of the product life cycle. We work across a broad spectrum of technologies and treatment modalities; our clients develop both next generation and paradigm shifting devices. Our product exposure includes implants, single use disposables, instruments (manual, laser, robotic, etc.), capital equipment, combination products, software as a medical device (SaMD), medical apps, in vitro diagnostics and more.

We are seeking a Software Quality Engineer to support our senior Quality team. The Software Quality Engineer will organize and manage the Quality activities for clients to help identify and meet Quality Management System (QMS) needs. Additionally, the Software Quality Engineer will evaluate Design Outputs and Design Changes for quality requirements, work with clients to assure quality, risk, or other management plans for equipment and processes for general and specific product performance needs are established according to the client’s QMS. These activities must be in accordance with industry standards and testing including as applicable, FDA Quality System Regulation, ISO 13485, ISO 14971, ISO 62304, ISO 82304 and the EU Medical Devices Regulation.

This position requires that you work in our San Jose office.

MAJOR DUTIES OF POSITION:

  • Administer Device Design and Change Control and perform quality engineering activities. This will include working with clients to assure Design Control and Design Change activities are completed correctly and in a timely manner. Including assisting them with development and reviewing software lifecycle management documentation.
  • Work with cross-functional teams to assure adequate testing strategies are developed and verification and validation plans are executed according to established schedules and procedures, including reviewing test protocols and reports for completeness and compliance.
  • Work with development engineers, product marketing, and project management to assure product/software requirements are documented traceable to testing and design outputs in the software design specification(s).
  • Support design team in performing and properly documenting development activities such as requirements analysis, use case development, and risk management performed to ensure that the device verification and validation is complete, the product is safe and of high quality, and that the quality system documentation as well as the product meet all regulatory requirements.
  • Support software maintenance, including software patches and software updates to verify that all appropriate documentation is established, reviewed and revised appropriately, including assuring new features have been properly specified and tested and regression testing of devices has been performed to assure continued safety and effectiveness after changes have been implemented.
  • Maintain accountability for project timelines and deliverables to both internal and external stakeholders.
  • Support other quality system related activities, including complaint handling, CAPA investigation and supplier evaluations to assure these activities are performed and documented correctly and in a timely manner according to the client’s established QMS.

KNOWLEDGE AND SKILL REQUIREMENTS:

  • Bachelor degree in Engineering or Life Sciences required.
  • Minimum 2 years’ experience with medical device companies whose products contain or are software for Quality Software Engineer I/II
  • Minimum 4 years’ experience with medical device companies whose products contain or are software for Senior Quality Software Engineer
  • High attention to detail and time management skills for self and others required .
  • Working knowledge of medical device regulations and standards (i.e., QS Regulation, ISO 13485, ISO 14971 series, ISO 62304, and ISO 82304,) required.
  • Experience with additional medical device regulations including ISO 60601 series, ISO 62366 series, ISO 10993 series, ISO 11135, and ISO 11137 desired.
  • Understanding of the full product life cycle for a medical device and an understanding of the differences between product lifecycles for traditional PEMs devices vs SaMD..
  • Strong computer science fundamentals including data structures, programming experience and an understanding of fundamental algorithms is a plus.
  • Experience with automation testing frameworks such as Selenium, Webdriver, TestNG is a plus.
  • Understanding of concepts and principles of Quality Assurance with respect to new product development, regulatory bodies, external suppliers, product manufacturing and product maintenance required.
  • Excellent verbal and writing skills including the ability to make others achieve deadlines and required commitments is required.

BENEFITS:

  • Medical, Dental and Vision Benefits
  • 18 Days of Paid Time-Off (PTO)
  • 11 Paid Holidays
  • 401(k)

The above description is intended to describe the general content, identify the essential functions of, and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or requirements.

Please send your resume.
Clinical Research Associate I/II/Sr.

We are seeking an experienced Clinical Research Associate to support our clinical operations team.

Clinical Research Associate I/II/Sr.

We are a dynamic group of professionals providing regulatory, quality and clinical services for the medical device industry. Our team supports start-ups, mid-sized private companies and large corporations at all stages of the product life cycle. We work across a broad spectrum of technologies and treatment modalities; our clients develop both next generation and paradigm shifting devices. Our product exposure includes implantables, instruments (manual, laser, robotic, etc.), capital equipment, combination products, software as a medical device (SaMD), medical apps, in vitro diagnostics and more.

We are seeking an experienced Clinical Research Associate (CRA) to support our clinical operations team. The CRA will act as project resource to clinical site, sponsor, and Experien Group personnel regarding the product under test and the clinical trial conduct. The person will participate in the planning, development and execution of clinical trials to evaluate the safety, effectiveness and performance of medical devices. Under management supervision, CRAs monitor assigned clinical trials to ensure adherence to Federal regulations, clinical protocol, company policies, and any other applicable procedures.

MAJOR DUTIES OF POSITION:

  • Responsible for ensuring that the site coordinators and investigators comply with the study protocol, Good Clinical Practices (GCP), Code of Federal Regulations (CFR) and Institutional Review Board (IRB)/Ethics Committee (EC) requirements.
  • Act as primary liaison to the site. Activities may include site qualification visits, site initiation visits and training, monitoring visits to review the study data and verify the accuracy of the data against the site’s medical records, and site close-out visits.
  • Contribute to protocol and CRF development as well as progress reports and the final clinical study report at study conclusion to report the study results to the FDA and other regulatory authorities.
  • Ensuring data quality by maintaining compliance, reviewing adverse events and device complaints, reviewing audit reports, and implementing corrective actions (when needed).
  • Support maintenance of department SOPs and work instructions.
  • Support investigational device administration including all documentation for forecasting, shipping, receiving, disposition, complaints, and returned goods.
  • Support and maintain documentation of all clinical research activities, e.g. site communications, correspondence, inventory information.
  • Assist with site start-up activities, including collection of site personnel documents and with supervision, review of clinical site-specific informed consents.
  • Ensure compliance with protocol and all regulatory policies, procedures and/or guidelines during clinical studies by training/guidance of investigators/research coordinators, conducting periodic on-site evaluations and follow-up of corrective actions.
  • Maintain working knowledge of clinical trial regulations for applicable geographies and types of studies. Serves as a resource related to clinical trial regulations.
  • Drive trial enrollment and identify and communicate potential and actual obstacles to enrollment.
  • Travel requirement: 25-50%

KNOWLEDGE AND SKILL REQUIREMENTS:

  • A minimum of 3 years of directly related work experience or equivalent in clinical research, including work on medical device trials
  • RN, BSN, or BS/BA in a relevant scientific discipline
  • Knowledge of GCPs, CFRs and IRB procedures
  • Accuracy, reliability, and high level of attention to detail
  • Strong level of professionalism, including verbal and written skills
  • Proficiency in using Microsoft Office Suite, including Word, Excel, Outlook and PowerPoint
  • Ability and willingness to travel

BENEFITS

  • Medical, Dental and Vision Benefits
  • 18 Days of Paid Time-Off (PTO)
  • 11 Paid Holidays
  • 401(k)

The above description is intended to describe the general content, identify the essential functions of, and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or requirements.

Please send your resume.
Clinical Project Manager/Clinical Operations Manager

We are seeking an experienced Clinical Project Manager/Clinical Operations Manager to support our clinical operations team.

Clinical Project Manager/Clinical Operations Manager

We are a dynamic group of professionals providing regulatory, quality and clinical services for the medical device industry. Our team supports start-ups, mid-sized private companies and the largest corporations at all stages of the product life cycle. We work across a broad spectrum of technologies and treatment modalities; our clients develop both next generation and paradigm shifting devices. Our product exposure includes implantables, instruments (manual, laser, robotic, etc.), capital equipment, combination products, software as a medical device (SaMD), medical mobile apps, in vitro diagnostics and more.

We are seeking an experienced Clinical Project Manager/Clinical Operations Manager to support our clinical operations team. The Clinical Project Manager/Clinical Operations Manager will participate in the planning, development and execution of clinical trials to evaluate the safety, effectiveness and performance of medical devices. Clinical Project Manager/Clinical Operations Managers oversee the development of clinical reports supporting regulatory submissions and provides clinical direction to development teams. This person will establish and direct clinical operations to ensure compliance with applicable laws, regulations, and company Standard Operating Procedures (SOPs) and policies governing clinical studies. They are also responsible for ensuring all activities are in compliance with Quality System requirements.

MAJOR DUTIES OF POSITION:

  • Establishes, implements and manages clinical study projects for clients.
  • Directs clinical projects and activities including: resourcing; project planning and clinical study design development; collaborating with other functional groups to establish and implement strategic and tactical plans that are consistent with client objectives; establishing and monitoring clinical timelines and budgets; and communicating clinical requirements and strategies to clinical staff team members.
  • Directs and provides effective communication to ensure that the clinical team understands and plans for all necessary clinical activities in order to successfully establish clinical study objectives and support required regulatory submissions.
  • Oversees the development of core clinical documents, including the clinical study protocol, case report forms (CRFs), informed consent forms, clinical study agreements, and all other documentation necessary for study initiation.
  • Oversees clinical staff to ensure appropriate identification and qualification of investigational sites for clinical trials.
  • Oversees clinical staff to ensure appropriate preparation and submission of required documentation to Institutional Review Boards (IRBs) for approval.
  • Ensures maintenance of approval throughout the duration of the study and ensures compliance to IRB reporting requirements and with national and international regulations.
  • Helps to ensure appropriate training is provided to clinical investigators and staff regarding data collection and reporting requirements as necessary.
  • Ensures clinical studies are conducted in compliance with the respective investigational plan and all applicable regulations, IRB requirements, and Company policies and procedures.
  • Oversees data management system, including development and implementation of systems to ensure the proper recording, collection, verification, validation, processing, analysis and storage of information collected in a Clinical Study.
  • Oversees operation to ensure all necessary documentation, including contract agreements are executed, signed and archived.
  • Provides progress reports in compliance with federal reporting requirements to regulatory agencies, IRBs, Investigators and senior management.
  • Oversees development and/or updating of clinical-specific procedures to ensure continued compliance with changing domestic and international regulatory requirements and to align with corporate policies/procedures.
  • Supports Regulatory Affairs with regulatory filings/registrations when necessary, such as but not limited to: support for the development of IDE submissions, development of clinical reports for 510(k)s, De Novos, and PMAs as applicable, and clinical expertise related to FDA submission questions and literature reviews to strengthen substantial equivalence positions.
  • Travel requirement: 25-50%

KNOWLEDGE AND SKILL REQUIREMENTS:

  • A minimum of 5 years of directly related work experience or equivalent in clinical research, including work on medical device trials
  • BS or BA degree required, science or related field preferred:
  • 7+ years’ experience in regulated industry with Bachelors

  • 5+ years’ experience in regulated industry with Masters or other Advanced Degree

  • Working knowledge of Good Clinical Practices (GCPs), FDA regulations and IRB procedures
  • Accuracy, reliability, and high level of attention to detail
  • Strong level of professionalism, including verbal and written skills
  • Proficiency in using Microsoft Office Suite, including Word, Excel, Outlook and PowerPoint
  • Experience interfacing successfully with physicians/clinical staff and familiarity with hospital/clinical environments
  • Familiarity with medical and anatomical terminology
  • Demonstrated ability to manage projects
  • Ability and willingness to travel

BENEFITS

  • Medical, Dental and Vision Benefits
  • 18 Days of Paid Time-Off (PTO)
  • 11 Paid Holidays
  • 401(k)

The above description is intended to describe the general content, identify the essential functions of, and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or requirements.

Please send your resume.
Regulatory Affairs Director/Sr. Regulatory Affairs Director

We are seeking an experienced Regulatory Affairs Director/Senior Regulatory Affairs Director to support U.S. and international regulatory activities, as well as be an individual contributor on regulatory projects for Experien Group clients.

Regulatory Affairs Director/Sr. Regulatory Affairs Director

We are a dynamic group of professionals providing regulatory, quality and clinical services for the medical device industry. Our team supports start-ups, mid-sized private companies and the largest corporations at all stages of the product life cycle. We work across a broad spectrum of technologies and treatment modalities; our clients develop both next generation and paradigm shifting devices. Our product exposure includes implantables, instruments (manual, laser, robotic, etc.), capital equipment, combination products, medical mobile apps, in vitro diagnostics and more.

We are seeking an experienced Regulatory Affairs Director/Senior Regulatory Affairs Director to support U.S. and international regulatory activities, as well as be an individual contributor on regulatory projects for Experien Group clients.

MAJOR DUTIES OF POSITION:

  • Responsible for managing and prioritizing work load for Experien Group’s regulatory staff.
  • Develops and establishes strategic regulatory plans and interfaces with project team members, both within the organization and with a diverse range of clients, to drive client corporate initiatives to completion.
  • Assumes a leadership role for project management. Works independently to represent regulatory affairs on project teams bringing novel products and manufacturing processes from concept, through development, to market for clients. Ensures product registration requirements are understood by project teams in order to create technical reports during development that will support global registrations.
  • Reviews and approves product labeling and marketing materials, including websites and social media. Initiates new package inserts and other required product labeling.
  • Manages/prepares elements of regulatory submissions (e.g., IDEs, 510(k)s, de novos, PMAs, HDEs, Technical Files, Design Dossiers, and international registrations).
  • Manages preparation and submission of pre-submission packages, Humanitarian Use Device designation requests and Non-Significant Risk proposals to support regulatory and clinical activities for clients.
  • Prepare regulatory/clinical strategy packages for executive review, including performing predicate research and relevant literature review from peer-reviewed journals.
  • Reviews/participates in preparing client design history file documentation, including verification/validation testing, biocompatibility, sterilization, transit and aging documentation, risk management documentation and device draft labeling.
  • Prepare/reviews Clinical Evaluation Reports for executive review in accordance with current requirements.
  • Reviews clients’ complaint files (including submission of MDRs, Vigilance Reports and Mandatory Problem Reports).
  • Supports regulatory field actions for clients.

KNOWLEDGE AND SKILL REQUIREMENTS

  • A technical degree is required, master’s preferred.
  • A minimum of 10 years of related work experience for Director.
  • A minimum of 15 years of related work experience for Senior Director.
  • Cardiovascular and Digital Health (SaMD) experience highly desired.
  • Knowledge of FDA’s Quality System Regulation (QSR) and the changing EU Medical Device Regulation (MDR) is required.
  • High level of professionalism, including strong verbal and written skills, is mandatory.
  • Strong leadership attributes are necessary. Candidate will lead cross-functional discussion and drive projects to completion. Mentors junior staff on regulations and company policies and procedures.
  • Candidate should possess exceptional project management and technical writing skills.

BENEFITS

  • Medical, Dental and Vision Benefits
  • 18 Days of Paid Time-Off (PTO)
  • 11 Paid Holidays
  • 401(k)

The above description is intended to describe the general content, identify the essential functions of, and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or requirements.

Please send your resume.
Regulatory Affairs Manager/Sr. Regulatory Affairs Manager

We are seeking an experienced Regulatory Affairs Manager/Senior Regulatory Affairs Manager to support U.S. and international regulatory activities as well as be an individual contributor on regulatory projects for Experien Group clients.

Regulatory Affairs Manager/Sr. Regulatory Affairs Manager

We are a dynamic group of professionals providing regulatory, quality and clinical services for the medical device industry. Our team supports start-ups, mid-sized private companies and the largest corporations at all stages of the product life cycle. We work across a broad spectrum of technologies and treatment modalities; our clients develop both next generation and paradigm shifting devices. Our product exposure includes implantables, instruments (manual, laser, robotic, etc.), capital equipment, combination products, medical mobile apps, in vitro diagnostics and more.

We are seeking an experienced Regulatory Affairs Manager/Senior Regulatory Affairs Manager to support U.S. and international regulatory activities as well as be an individual contributor on regulatory projects for Experien Group clients.

MAJOR DUTIES OF POSITION:

  • Develops and establishes strategic regulatory plans and interfaces with project team members, both within the organization and with a diverse range of clients, to drive client corporate initiatives to completion.
  • Assumes a leadership role for project management. Works independently to represent regulatory affairs on project teams bringing novel products and manufacturing processes from concept, through development, to market for clients. Ensures product registration requirements are understood by project teams in order to create technical reports during development that will support global registrations.
  • Reviews and approves product labeling and marketing material, including websites and social media. Initiates new package inserts and other required product labeling.
  • Manages/prepares elements of regulatory submissions (e.g., IDEs, 510(k)s, PMAs, HDEs, Technical Files, Design Dossiers, and international registrations).
  • Manages preparation of for pre-submission packages, Humanitarian Use Device designation requests and Non-Significant Risk proposals for regulatory and clinical activities.
  • Prepares regulatory/clinical strategy packages for executive review, including performing predicate research and relevant literature review from peer reviewed journals.
  • Reviews clients’ design history file documentation, including verification/validation, biocompatibility, sterilization, transit and aging documentation, risk management documentation and device draft labeling.
  • Prepares Clinical Evaluation Reports for executive review in accordance with current standards.
  • Processes and reviews clients’ complaint files (including submission of MDRs, Vigilance Reports and Mandatory Problem Reports).

KNOWLEDGE AND SKILL REQUIREMENTS

  • A technical degree is required, master’s preferred.
  • A minimum of 7 years related work experience for Manager.
  • A minimum of 10 years related work experience for Senior Manager.
  • Cardiovascular and Digital Health (SaMD) experience highly desired.
  • Knowledge of FDA’s Quality System Regulation (QSR) and the changing EU Medical Device Regulation (MDR) is required.
  • High level of professionalism, including strong verbal and written skills, is mandatory.
  • Strong leadership attributes are necessary. Candidate will lead cross-functional discussion and drive projects to completion. Mentors junior staff on regulations and company policies and procedures.
  • Candidate should possess exceptional project management and technical writing skills.

BENEFITS

  • Medical, Dental and Vision Benefits
  • 18 Days of Paid Time-Off (PTO)
  • 11 Paid Holidays
  • 401(k)

The above description is intended to describe the general content, identify the essential functions of, and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or requirements.

Please send your resume.
Regulatory Affairs Associate I/II/Sr.

We are seeking an accomplished Regulatory Affairs Associate to assist our senior Regulatory staff with U.S. and international strategies, submissions, and reporting/compliance activities.

Regulatory Affairs Associate I/II/Sr.

We are a dynamic group of professionals providing regulatory, quality and clinical services for the medical device industry. Our team supports start-ups, mid-sized private companies and the largest corporations at all stages of the product life cycle. We work across a broad spectrum of technologies and treatment modalities; our clients develop both next generation and paradigm shifting devices. Our product exposure includes implantables, instruments (manual, laser, robotic, etc.), capital equipment, combination products, medical mobile apps, in vitro diagnostics and more.

We are seeking an accomplished Regulatory Affairs Associate to assist our senior Regulatory staff with U.S. and international strategies, submissions, and reporting/compliance activities. We are looking for a technically strong, self-directed and collaborative individual to work within our organization and in a variety of client settings per project dictates. This Regulatory Affairs Associate will report to a Vice President of Regulatory and must be able to collaborate with our Regulatory, Quality and Clinical staff as well as work independently on appropriate level tasks.

MAJOR DUTIES OF POSITION:

  • Generates/oversees content for and prepares FDA regulatory submissions for device commercialization (e.g., 510(k)s, PMAs, HUD/HDEs and de novos, as well as FDA responses).
  • Performs predicate research for medical devices.
  • Performs research and assists in defining regulatory and clinical strategies.
  • Summarizes and positions literature review searches from peer-reviewed journals.
  • Supports numerous regulatory compliance activities, including processing of complaints and submitting Medical Device Reports and Vigilance Reports.
  • Assists in CE Marking activities, including preparation of Clinical Evaluation Reports, Technical Files and Design Dossiers.
  • Supports the preparation of pre-submission and IDE packages in preparation for human clinical testing as well regulatory support for IRB submissions.
  • Interact with European Authorized Representative.
  • Interact with country regulatory authorities as needed.
  • Participate and Interact with external ISO and FDA audits.
  • Participate in design reviews.

KNOWLEDGE AND SKILL REQUIREMENTS

  • A bachelor’s degree is required, master’s preferred.
  • A minimum of 2 years of related medical device experience expected for Associate I/II.
  • A minimum of 6 years of related medical device experience expected for Senior Associate.
  • Knowledge of FDA Regulations and the changing EU Medical Device Regulation (MDR) is required.
  • Strong level of professionalism, including verbal and written skills, is necessary; must be prepared to work in a variety of client settings.

BENEFITS

  • Medical, Dental and Vision Benefits
  • 18 Days of Paid Time-Off (PTO)
  • 11 Paid Holidays
  • 401(k)

The above description is intended to describe the general content, identify the essential functions of, and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or requirements.

Please send your resume.
General Application

If you do not currently see a vacancy that fits your area of expertise, please feel free to submit a resume for us to keep on file for future listings.

General Application

If you do not currently see a vacancy that fits your area of expertise, please feel free to submit a resume for us to keep on file for future listings.

Please send your resume.