Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

We're hiring a Senior Regulatory Affairs Specialist to support U.S. and global regulatory submissions for medical devices and partner with cross-functional teams to ensure regulatory compliance throughout the product lifecycle.

Key Responsibilities

• Prepare and support submissions including IDEs, 510(k)s, CE Technical Documentation, UKCA, and global registrations
• Maintain regulatory approvals and submission documentation
• Review design control documents, labeling, and quality system procedures
• Support regulatory agency interactions and responses
• Collaborate with R&D, Quality, Clinical, and Marketing teams
• Monitor regulatory changes and competitor activities
• Assist with SOPs, process improvements, and post-market activities

Qualifications

• Bachelor's degree in a scientific or engineering discipline
• 4+ years of medical device Regulatory Affairs experience
• Experience with FDA and international regulatory submissions
• Knowledge of FDA regulations, Design Controls, ISO 13485, and global medical device requirements
• Strong communication, organization, and project management skills

Additional Information

Hybrid role based in Alameda, CA
10-30% travel as needed
No current or future visa sponsorship available
Equal Opportunity Employer

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