
Medical Device and Pharmaceutical Compliance Expert
3 days ago
The Regulatory Affairs Specialist plays a vital role in ensuring compliance with international, federal, and local regulations. This includes preparing, reviewing, and submitting regulatory documentation to global health authorities.
- Prepared, reviewed, and submitted regulatory filings, including IND, NDA, ANDA, DMF, 510(k), PMA, CE Technical Files, and related applications.
- Ensured compliance with international, federal, and local regulatory requirements across pharmaceuticals and medical devices.
- Developed and maintained regulatory strategies to support new product development and lifecycle management.
- Maintained up-to-date knowledge of regulatory changes, guidelines, and industry best practices to ensure organizational compliance.
Key Responsibilities:
Our ideal candidate will have a strong background in regulatory submissions, product lifecycle management, and cross-functional collaboration to support product development, registration, and commercialization.
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