About this opportunity
LHH lists this Senior Regulatory Affairs Specialist opportunity in dublin, California. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Overview
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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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
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Worksite address
dublin, CA, 94568, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.