Job Summary

A global science and technology manufacturing company has a current position open for a Remote Manufacturing Staff Regulatory Affairs Specialist.

Must be able to:

• Author global pre-market submissions, including 510(k)s and PMA supplements
• Create and manage Technical Files in compliance with IVDD and IVDR
• Ensure sound post-market product regulatory strategies

Applicants must meet the following qualifications:

• Bachelor's Degree with 9+ years of experience in Life Sciences
• Or a Master's Degree with 7+ Years of experience in Life Sciences
• Or Doctorate with 4+ years of experience in Life Sciences
• Subject matter expertise in registration and commercialization of medical devices, including 510(k) to the FDA
• Demonstrated experience developing effective pre-market regulatory strategies