Regulatory Affairs Specialist II – Structural Heart (on-site)
Core
Performs specialized regulatory activities for a transcatheter heart valve replacement device, including preparing FDA and international regulatory applications, reviewing engineering changes, and supporting product market entry.
Role type
Individual contributor Regulatory Affairs Specialist
Builds
Regulatory submissions and documentation for transcatheter heart valve devices
Domain
Medical Devices / Structural Heart
Required skills
Regulatory application preparation (510(k), IDE, PMA), Engineering change review, Device labeling review, Regulatory guideline analysis, Communication with regulatory agencies, GTS license creation, Protocol and report review, QMS/EMS compliance
Preferred skills
Clinical trial regulatory experience, Cross-division business unit experience, Medical Device industry experience, RAPS Certification
Technologies
FDA submission systems, International regulatory databases, GTS license systems
Responsibilities
Prepare robust regulatory applications for FDA or international agencies; Create, review, and approve engineering changes; Review and provide input on device labeling; Interface directly with FDA and other regulatory agencies; Support product release process by creating GTS licenses; Maintain domestic and international medical device regulations
Seniority
Mid-level, hands-on IC