Are you an experienced regulatory expert looking for your next consulting opportunity?
Compliance Insight is actively seeking 1099 Medical Device Consultants to support our growing client base with high-impact regulatory projects.
Compliance Insight is actively recruiting for 1099 regulatory consultants to support clients requesting assistance with the medical device industry.
About the Role -
As a consultant with Compliance Insight, you'll work directly with medical device companies to:
- Provide strategic regulatory guidance ensuring compliance with FDA and global requirements
- Lead or support the design, execution, and analysis of regulatory strategies
- Prepare and submit 510(k) applications via eSTAR (Traditional, Abbreviated, and Special)
- Serve as a liaison with regulatory authorities, offering clear and timely communication
- Stay current on evolving regulations and standards to advise clients proactively
What We're Looking For:
- Minimum of 15 years of industry experience
- Knowledge and application of eSTAR for Traditional, Abbreviated, and Special 510(k)s
- Proven track record of successful involvement in the preparation and submission of 510k filings
- Strong analytical, problem-solving, and communication skills
- Ability to work independently as a contractor (1099 status)
Preferred Skills Experience with PMA, IDE, Q-Submissions, Breakthrough Devices