Senior Regulatory Affairs Specialist
Core
Senior Regulatory Affairs Specialist supporting the Urology division's active implantable device portfolio with submissions and compliance.
Role type
Senior Regulatory Affairs Specialist (Medical Devices)
Builds
Regulatory submissions (510(k), EU MDR) and compliance strategies for active implantable devices
Domain
Medical Devices / Urology
Required skills
Regulatory submissions (510(k), EU MDR), regulatory impact assessment, test protocol review, labeling review, cross-functional collaboration, international regulatory filings
Preferred skills
PMA submissions, Class III devices, long-term implants, product development lifecycle, design control, project management
Technologies
Microsoft Office
Responsibilities
Review change notifications and perform regulatory impact assessments; Support coordination and submission of US and EU regulatory filings; Provide technical reviews of test protocols and reports; Assess labeling materials including Instructions for Use; Represent RA on cross-functional project teams; Liaise with international regulatory colleagues; Support major business segment product lines and strategic initiatives