Job qualifications and
|Minimum Education Required:
Bachelor's Degree (or equivalent); Bachelor's Degree in science (biology; chemistry; microbiology; immunology; medical technology; pharmacy; pharmacology); math; engineering; or medical fields is preferred. M.S. in a technical area or M.B.A. is preferred.
A Ph.D. in a technical area or law is helpful. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
Minimum Experience / Training Required:
2-5 years of experience in regulatory preferred but may consider quality assurance,
research and development/support, scientific affairs, operations, or related area.
4-5 years experience in a regulated industry (e.g., medical products, nutritionals).
Preferred Experience, Education, etc.:
5-7 years of Regulatory medical device experience (IVD preferred)
2-3 years experience with 510(k) clearances (in-person FDA meetings preferred)
2-3 years experience with CE Technical Files competed, with Notified Body approvals
Experience with MDR (IVDR preferred)
Experience independently managing projects that led to product launches from Regulatory perspective
Experience with effective cross-functional team interaction, etc.