Principal Regulatory Affairs Specialist at a Cutting-Edge Global Medical Device Company
Employer
Biolink360
Salary
$210k-$240k (estimated pay)
Location
Mountain View, CA
Employment Type
Full-time
Сategory
Biomedical Engineers
Description
Exciting opportunity to join a global leader in medical devices as a Principal Regulatory Affairs Specialist.
Qualifications
- 5-10 years experience in regulatory affairs within the medical device industry
- Strong experience in EUMDR Regulations
- Authoring experience in FDA product submissions
- Experience with ISO 13485:2016 and ISO 14971
Responsibilities
- Support and prepare all regulatory submissions for FDA, Health Canada, Notified Bodies, and other regulatory agencies
- Provide guidance and approval regarding regulatory strategies and approaches
- Develop, maintain, and update regulatory documents such as technical files for CE marking
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