Senior Regulatory Affairs Specialist
$110,000–$150,000 year
On-site · Pleasanton, California, United States
Job Summary
Senior Regulatory Affairs Specialist to develop global regulatory strategies, prepare submissions (FDA 510(k), De Novo, EU MDR), manage registrations, coordinate with authorities and notified bodies, support international market expansion, lifecycle and change control support, and ensure regulatory compliance across US, EU, APAC, LATAM, and MEA; collaborate cross-functionally with R&D, Quality, Clinical, Manufacturing, Supply Chain, and Marketing to integrate regulatory requirements into product development and commercialization; maintain regulatory records, review labeling and promotional materials, and support audits and post-market surveillance.
Required Qualifications
- Bachelor’s degree in Regulatory Affairs, Biomedical Engineering, Life Sciences, Engineering, or related discipline
- Must have at least 8+ years of work experience in the medical device industry
- Demonstrated experience preparing or supporting regulatory submissions (510(k) and Technical Documentation experience required)
- Experience with S., EU, Canada, APAC, LATAM, MEA.
- Experience with product registrations and international regulatory activities
- Strong project management skills
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