Senior Regulatory Affairs Specialist

LHH; Dublin (CA); On-site; USD 110,000 - 150,000; Full time

Job summary

LHH is seeking a Senior Regulatory Affairs Specialist in Dublin, California to support global regulatory strategies for medical devices. The role involves preparing submissions, leading communications with regulatory agencies, and ensuring compliance with evolving regulations.

The ideal candidate has over 8 years of experience in regulatory affairs, particularly with FDA 510(k) and EU MDR submissions. Strong project management and technical writing skills are essential.

Qualifications

• 8+ years of regulatory affairs experience within the medical device industry.
• Strong experience with FDA 510(k) submissions and EU MDR / Technical Documentation.
• Knowledge of FDA regulations, ISO 13485, ISO 14971, and global regulatory frameworks.

Responsibilities

• Develop and execute regulatory strategies for Class I–II medical devices.
• Prepare and manage submissions including FDA 510(k), EU MDR Technical Documentation, and global registrations.
• Lead regulatory communications with U.S. and international agencies.

Skills

Regulatory affairs experience

FDA 510(k) submissions

EU MDR Technical Documentation

Project management

Technical writing

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

Send Resumes to: [e-mail]

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