Regulatory Affairs Specialist II
Penumbra · Alameda, CA
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Role summary
Regulatory Affairs Specialist II at Penumbra prepares and maintains regulatory submission documentation for medical devices across global markets. The role involves coordinating approvals for clinical research and commercial distribution while ensuring compliance with international regulatory standards.
What they're looking for
- Bachelor's degree in science or related field with 2+ years experience
- Regulatory medical device experience preferred
- Strong written and oral communication skills
- Proficiency with MS Word, Excel, and PowerPoint
- Excellent organizational and multi-project prioritization abilities
- High attention to detail and accuracy
What you'll be doing
- Prepare submissions for IDE, 510(k), CE-Mark, UKCA, and other regional regulatory approvals
- Track multiple concurrent projects and maintain existing approvals and documentation
- Communicate with regulatory agencies and in-country personnel to facilitate global clearances
- Review design control documents and quality system procedures for regulatory compliance
- Monitor competitor FDA clearances and research regulatory requirements for strategic planning
Compensation$90,000 - $125,000 base per year
Privacy & handoff
This role links to Penumbra's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.