Senior Manager, Regulatory Affairs
Core
Strategic leader driving global regulatory strategy and compliance for Stryker's Peripheral Vascular portfolio across the full product lifecycle.
Role type
Senior Manager, Regulatory Affairs (People Leadership)
Builds
Global regulatory strategy, compliance programs, and high-performing Regulatory Affairs teams
Domain
Medical Devices / Peripheral Vascular / Regulatory Affairs
Deliverable
client delivery
Required skills
Global regulatory strategy, product lifecycle management, regulatory submissions, team leadership, talent development, cross-functional partnership, risk management, project management
Preferred skills
Medical device industry experience, FDA regulations knowledge, EU MDR knowledge, 510(k) submission experience
Technologies
None stated
Responsibilities
Support global regulatory strategy across development, post-market changes, and obsolescence; Provide regulatory guidance on product claims, labeling, and IFUs; Assess product and manufacturing changes for regulatory impact; Monitor evolving regulatory requirements; Partner cross-functionally to integrate regulatory requirements; Lead regulatory operations including audits and authority interactions; Develop regulatory training and improve compliance systems; Build and lead a high-performing Regulatory Affairs team
Seniority
Senior Manager, People Leadership