Senior Regulatory Affairs Specialist

We are partnering with a growing, innovative medical device organization seeking a Senior Regulatory Affairs Specialist to support global regulatory strategy, submissions, and product lifecycle activities.

This is a high-impact opportunity to work cross-functionally and contribute to product development and international market expansion.

Title: Senior Regulatory Affairs Specialist (Medical Device)

Location: East Bay, CA

Send Resumes to: [email protected]

Key Responsibilities

• Develop and execute regulatory strategies for Class I–II medical devices
• Prepare and manage submissions including FDA 510(k), EU MDR Technical Documentation, CE Mark, and global registrations
• Lead regulatory communications with U.S. and international agencies
• Support global product registrations across the U.S., EU, Canada, APAC, and LATAM
• Evaluate regulatory impact of product, design, and labeling changes
• Conduct regulatory gap assessments and monitor evolving regulatory requirements
• Maintain regulatory documentation and ensure audit readiness
• Support post-market activities including MDR, vigilance reporting, and field actions
• Partner closely with R&D, Quality, Clinical, and Commercial teams

Qualifications

• 8+ years of regulatory affairs experience within the medical device industry
• Strong experience with FDA 510(k) submissions and EU MDR / Technical Documentation
• Experience supporting global regulatory activities and product registrations
• Knowledge of FDA regulations, ISO 13485, ISO 14971, and global regulatory frameworks
• Strong project management, communication, and technical writing skills

Preferred

• Regulatory Affairs Certification (RAC)
• Experience with digital health or SaMD

Candidates must be authorized to work in the U.S. without current or future sponsorship.

Equal Opportunity Employer/Veterans/Disabled

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act

• Los Angeles City Fair Chance Ordinance

• Los Angeles County Fair Chance Ordinance for Employers

• San Francisco Fair Chance Ordinance”