Regulatory Affairs Leader: FDA 510(k) & Global Compliance

medical device; Bothell (WA); Hybrid; USD 150,000 - 210,000; Full time

Job summary

Medical Device Company in Bothell, WA, is seeking a Manager, Regulatory Affairs to lead the Regulatory Affairs and Quality Assurance team at the Bothell headquarters. You will own FDA 510(k) submissions, guide global registrations, mentor staff, and shape regulatory strategy in collaboration with Engineering, Clinical, Quality, and Commercial teams.

The role reports to the Director of Regulatory Affairs and offers hybrid work with occasional travel.

Qualifications

• Bachelor's degree in a scientific or engineering discipline (or equivalent experience).
• 8+ years of related experience in a regulated quality environment, including 3 to 5+ years of direct people management.
• Demonstrated experience independently preparing and managing traditional 510(k)s, including substantial equivalence argumentation, performance testing summaries, and FDA deficiency responses.
• Working knowledge of FDA 21 CFR Parts 801, 807, and 820 and applicable guidance (De Novo, Special 510(k), Predetermined Change Control Plans).
• Experience with the FDA eSTAR submission format.
• Preferred: EU MDR Technical File preparation, Notified Body interactions, and EUDAMED registration experience.
• Preferred: RAC certification.
• Up to 10% international travel to support the company facilities and partners.

Responsibilities

• Serve as primary regulatory owner for FDA 510(k) submissions, including pathway strategy (Traditional, Abbreviated, Special 510(k)) and FDA deficiency responses.
• Lead global registration activities to obtain and maintain market authorizations across the device portfolio.
• Manage, mentor, and develop a team of Regulatory Affairs Specialists, setting performance expectations, holding regular 1:1s, and supporting professional growth.
• Own budget planning and tracking for the function, including headcount and vendor and consultant spend.
• Author and maintain regulatory SOPs, work instructions, and Letter to File assessments within the QMS.
• Monitor evolving FDA guidance and De Novo precedents affecting the company's device categories.
• Translate functional plans into operational processes and contribute to annual regulatory strategy and planning.
• Collaborate cross-functionally with Engineering, Clinical Affairs, Quality, and Commercial teams.
• Advise senior leadership on regulatory risk affecting business objectives.

Skills

Regulatory leadership

Team management

Cross-functional collaboration

Strategic planning

Budget management

Education

Bachelor's degree in science or engineering

Tools

FDA eSTAR

Job description

Medical Device Company in Bothell, WA, is seeking a Manager, Regulatory Affairs to lead the Regulatory Affairs and Quality Assurance team at the Bothell headquarters. You will own FDA 510(k) submissions, guide global registrations, mentor staff, and shape regulatory strategy in collaboration with Engineering, Clinical, Quality, and Commercial teams.

The role reports to the Director of Regulatory Affairs and offers hybrid work with occasional travel.