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
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 or call us.

Phone:
408-400-0856
Regulatory Affairs Associate II/Sr. Regulatory Affairs Associate – San Diego

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 in our San Diego office.

Regulatory Affairs Associate II/Sr. Regulatory Affairs Associate – San Diego

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 in our San Diego office. 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 Sr. Director 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 EU Medical Device Directive 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 or call us.

Phone:
408-400-0856