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
Document Control Specialist – San Jose

We are seeking an experienced Document Control Specialist who 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.

Document Control Specialist – San Jose

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 a Document Control Specialist who will be 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.
Please send your resume.
Regulatory Affairs Director

We are seeking an experienced 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

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 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 10-15 years of related work experience.
  • 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)
Please send your resume.
Regulatory Affairs Manager

We are seeking an experienced 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

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 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 5-8 years of related work experience.
  • 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)
Please send your resume.
Regulatory Affairs Associate II/Sr. Regulatory Affairs Associate

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 II/Sr. Regulatory Affairs Associate

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 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 2-5 years of related medical device experience expected.
  • 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)
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.