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

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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

Equal Opportunity Employer/Veterans/Disabled

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to

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"

Pay Details: $100,000.00 to $150,000.00 per year

Search managed by: Kathleen Calderara

Equal Opportunity Employer/Veterans/Disabled

Military connected talent encouraged to apply

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to

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

Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.