Senior Regulatory Affairs Specialist
Hyperfine
full-time
Posted on:
Location Type: Hybrid
Location: Palo Alto • California • 🇺🇸 United States
Visit company websiteSalary
💰 $125,000 - $145,000 per year
Job Level
Senior
About the role
- Advise regulatory strategy for company’s devices
- Ensure compliance to regulatory requirements for assigned regions
- Translate complex regulatory requirements into practical plans
- Interact with regulatory agencies and senior leadership
- Represent Regulatory for product development
- Ensure submissions and registrations are authored and submitted on time
- Guide teams on regulatory issues
- Maintain US FDA establishment registrations and device listing
Requirements
- Bachelor’s degree in a scientific or regulatory discipline
- 8 years' experience in the medical device industry; or equivalent work experience
- Minimum 5 years' experience in Regulatory Affairs role
- Experience interpreting FDA and international guidelines and regulations
- History of successful US FDA 510(k) clearances for Class II devices and interactions with regulators
- Experience with EU MDR, Health Canada, and Australia TGA regulatory submissions
- Experience with international registrations
- Proven track record of navigating swiftly and efficiently through the regulatory process as part of a team
Benefits
- Health insurance
- Corporate bonus
- Equity plans
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory strategyregulatory complianceFDA guidelinesEU MDRHealth Canada regulationsAustralia TGA submissionsUS FDA 510(k) clearancesinternational registrationsregulatory submissionsdevice listing
Soft skills
communicationleadershipteam collaborationproblem-solvingadvisory skills
Certifications
Bachelor’s degree in scientific disciplineBachelor’s degree in regulatory discipline