3h ago
Sr. Manager, Regulatory Affairs
San Jose, California
$163,000-$221,000 / year
full-timeseniormedical device
Requirements
- Bachelor's degree in scientific or engineering discipline
- Minimum 8 years regulatory affairs experience in medical device industry
- In-depth knowledge of FDA regulations (21 CFR Part 820) and ISO 13485
- Proven track record of successful 510(k) submissions
- Regulatory affairs certifications (RAC)
Responsibilities
- Develop and execute regulatory strategies for US medical device registration and commercialization
- Provide regulatory guidance to cross-functional teams throughout product lifecycle
- Manage and review regulatory submissions including 510(k), De-Novo, Pre-submissions, and IDEs
- Maintain regulatory documentation and product registrations
- Coordinate with regulatory authorities like FDA and notified bodies
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