1099 Medical Device Regulatory Consultant Job at Compliance Insight, Inc., Cincinnati, OH

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  • Compliance Insight, Inc.
  • Cincinnati, OH

Job Description

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

Job Tags

For contractors,

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