Description
The Senior Regulatory Affairs Specialist is responsible with the coordinating, preparing, and maintaining regulatory submissions.- Prepare, coordinate and submit 510(k) and CE submissions
- Provide regulatory support to assure compliance of marketed products
- Provide regulatory leadership to cross-functional teams regarding strategy, current standards and regulations
- Assist with notified body audits
- Assist with MDR and Vigilance reporting as needed.
- Participate with project taems to define requirements for U.S. and international submissions.
- Write SOP's as necessary
Qualifications:
- Knowledge of ISO 13485, QSR, etc.
- Knowledge of IVDD (98/79/EC)
- Experience with 510(k) and CE-Mark Submissions
- B.S. Degree
To find out more about Real Staffing please visit www.realstaffing.com