Senior Regulatory Affairs Specialist
Core
Senior Regulatory Affairs Specialist supporting product and manufacturing changes, regulatory submissions, and compliance for the Interventional Therapies Division.
Role type
Senior IC regulatory affairs specialist
Builds
Regulatory submissions and compliance documentation for medical devices
Domain
Medical devices / Interventional Therapies
Required skills
regulatory strategy, regulatory submissions (US/EU/international), EU MDR technical documentation, cross-functional collaboration, risk identification, regulatory authority liaison, team mentoring
Responsibilities
Review complex product and manufacturing changes for regulatory compliance; Lead coordination and writing of US, EU, and international regulatory submissions; Maintain EU MDR Technical Documentation; Represent RA on cross-functional project teams; Support interactions with regulatory authorities and Notified Bodies; Provide regulatory guidance and mentoring to team members
Seniority
Senior, hands-on IC