Regulatory Affairs Manager, FDA 510(k) & Global Compliance

Cypress HCM; Bothell (WA); Hybrid; USD 170,000 - 230,000; Full time

Job summary

Medical Device Company in Bothell, WA, is seeking a Manager of Regulatory Affairs to lead the Regulatory Affairs and Quality Assurance team at its Bothell headquarters. The role oversees FDA submissions, global registrations, and strategic regulatory initiatives, working closely with Engineering, Clinical, Quality, and Commercial teams.

The successful candidate will have 8+ years in regulated environments, strong 510(k) experience, and proven people management.

Qualifications

• Bachelor's degree in a scientific or engineering discipline.
• 8+ years in a regulated quality environment with 3–5+ years of people management.
• Experience preparing and managing traditional 510(k)s, incl. substantial equivalence & 510(k) responses.
• Working knowledge of FDA 21 CFR Parts 801, 807, and 820 and applicable guidance.
• Experience with 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 facilities and partners.

Responsibilities

• Serve as primary regulatory owner for FDA 510(k) submissions and related 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 with regular 1:1s.
• Own budget planning and tracking for the function, including headcount and vendor 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 device categories.
• Translate plans into operational processes and contribute to regulatory strategy.
• Collaborate cross-functionally with Engineering, Clinical Affairs, Quality, and Commercial teams.
• Advise senior leadership on regulatory risk affecting business objectives.

Skills

Regulatory affairs leadership

Team leadership

Strategic planning

Cross-functional collaboration

Budget management

FDA 510(k) expertise

Education

Bachelor's degree in a scientific or engineering discipline

Tools

FDA eSTAR

Job description

Medical Device Company in Bothell, WA, is seeking a Manager of Regulatory Affairs to lead the Regulatory Affairs and Quality Assurance team at its Bothell headquarters. The role oversees FDA submissions, global registrations, and strategic regulatory initiatives, working closely with Engineering, Clinical, Quality, and Commercial teams.

The successful candidate will have 8+ years in regulated environments, strong 510(k) experience, and proven people management.