What are the responsibilities and job description for the Senior Regulatory Affairs Specialist position at LHH?
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
Candidates must be authorized to work in the U.S. without current or future sponsorship.
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”
Salary : $100,000 - $150,000