SENIOR REGULATORY AFFAIRS SPECIALIST
Providence, RI 02910
Location: Providence, RI
Company: Top Medical Equipment / Devices
Compensation: $80K-$110K Base + Bonus + Amazing Benefits
Contact: Ken Kupersmith- [email protected]
Manage regulatory projects to ensure timely introduction of new products subject to medical device and combination product regulations in U.S. and global regions. Provide technical and administrative regulatory support to marketed products and ensure company's regulatory compliance status.
B.S. or equivalent with emphasis on Life Sciences. Professional certifications and advanced degree preferred.
- Knowledge and experience (5+ years) with regulatory requirements for medical devices and / or combination products (IDE's, PMA's 510(k)'s, CE mark technical files and design dossiers).
- Good oral and written communications skills - analytical thinking and technical writing; ability to work on cross-functional teams; ability to manage several parallel deliverables.
- Working knowledge of statistics and electronic documentation and information systems.
- Ability and desire to travel as needed.