Senior Regulatory Affairs Specialist, Medical Devices

Job overview

The Senior Regulatory Affairs Specialist role is hybrid in Sunnyvale, CA; compensation is $55–$60, with the posting not specifying a pay period. System One provides outsourced services and workforce solutions to clients. The specialist develops regulatory plans and submissions, assesses product and process changes, and advises cross-functional teams on regulatory strategy to support medical-device approvals and market implementation in the United States, Canada, and globally.

What you'll do

• Develop regulatory plans
• review design documentation and identify applicable standards
• assess regulatory impacts of design and process changes
• prepare and maintain FDA 510(k), Letters to File, pre-submissions, and Health Canada submissions
• advise product teams on regulatory strategy
• coordinate responses to agency requests
• assess impacts on design, materials, labeling, packaging, manufacturing processes, and facilities
• collaborate on global submissions and approvals
• lead documentation and author responses.

What we're looking for

Skills & competencies

senior regulatory affairs specialist

medical devices

sunnyvale ca

hybrid

fda 510(k)

health canada

eu mdr

regulatory submissions

design controls

global regulatory strategy

system one

$55–$60

Work arrangement

• Weekend coverage required

Benefits & perks

• Eligible employees may access medical, dental, vision, spending accounts, life insurance, voluntary plans, and a 401(k) plan.

Why this role

Medical-device regulatory experience; minimum eight years of regulatory affairs experience and a bachelor's degree or higher are specified; RAPS RAC certification is a plus.

About the employer

System One is hiring for this role. Industry: Regulation, Licensing, and Inspection of Miscellaneous Commercial Sectors. Sector: 92.