Financial Planning and Analysis Manager

Manager, Regulatory Affairs

Medical Device Company | Bothell, WA (Hybrid) | Regulatory Affairs & Quality Assurance | Full-Time

About the Role

A global medical device company is seeking a Manager, Regulatory Affairs to join its Regulatory Affairs and Quality Assurance team at its Bothell, WA headquarters. This leader owns the Regulatory Affairs function, managing a team of Regulatory Affairs Specialists (and, as the team scales, supervisors) responsible for obtaining and maintaining market authorizations across the company's global device portfolio. As the primary regulatory owner for FDA 510(k) submissions and global registrations, the Manager provides strategic oversight, technical review, and team development while partnering with Engineering, Clinical Affairs, Quality, and Commercial teams. The role reports to the Director of Regulatory Affairs.

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

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

#LI-ED1

Tagged as: Financial Modeling