Senior Regulatory Affairs Specialist (RE-12438013) San Jose, California
|Salary:||USD85000 - USD100000 per annum|
A global diagnostic company is seeking a senior RA Specialist to plan, coordinate and submit U.S. and international regulatory submissions/registrations.
- Plan, strategize, coordinate, and submit US and Global registrations
- Plan and submit EU IVDD tech files, design dossiers, 510(k) pre-market notifications
- Represent regulatory affairs on product core teams, providing regulatory guidance and strategy
- Provide materials review, experimental designs, data analysis, and product labeling
- Keep current with changes in worldwide regulations, standards, laws, etc.
- BA/BS Degree
- 3+ Years in FDA regulated environment
- 2+ Years submissions experience
- Experience with 510(k) Submissions
- Experience with EU tech files.