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: kathie.calderara@LHH.com

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 https://www.lhh.com/us/en/candidate-privacy

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 https://www.lhh.com/us/en/candidate-privacy

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.