Financial Planning and Analysis Manager

Manager, Regulatory AffairsMedical Device Company | Bothell, WA (Hybrid) | Regulatory Affairs & Quality Assurance | Full-TimeAbout the RoleA 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.ResponsibilitiesServe as primary regulatory owner for FDA 510(k) submissions, including pathway strategy (Traditional, Abbreviated, Special 510(k)) and FDA deficiency responsesLead global registration activities to obtain and maintain market authorizations across the device portfolioManage, mentor, and develop a team of Regulatory Affairs Specialists, setting performance expectations, holding regular 1:1s, and supporting professional growthOwn budget planning and tracking for the function, including headcount and vendor and consultant spendAuthor and maintain regulatory SOPs, work instructions, and Letter to File assessments within the QMSMonitor evolving FDA guidance and De Novo precedents affecting the company's device categoriesTranslate functional plans into operational processes and contribute to annual regulatory strategy and planningCollaborate cross-functionally with Engineering, Clinical Affairs, Quality, and Commercial teamsAdvise senior leadership on regulatory risk affecting business objectivesQualificationsBachelor'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 managementDemonstrated experience independently preparing and managing traditional 510(k)s, including substantial equivalence argumentation, performance testing summaries, and FDA deficiency responsesWorking 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 formatPreferred: EU MDR Technical File preparation, Notified Body interactions, and EUDAMED registration experiencePreferred: RAC certificationUp to 10% international travel to support the company facilities and partners#LI-ED1