Regulatory Affairs Specialist
Core
Supports global regulatory compliance for medical devices used in organ transplantation, managing submissions, licenses, and post-market surveillance across Canada, US, EU, and other jurisdictions.
Role type
Regulatory Affairs Specialist
Builds
Regulatory submissions, product licenses, and compliance documentation for medical device products
Domain
Medical Devices / Organ Transplantation
Required skills
Regulatory submissions, license maintenance, adverse event reporting, gap analysis, audit support, UDI listing management, regulatory impact assessment
Preferred skills
Complaint handling, post-market surveillance, technical/clinical information interpretation
Technologies
ISO 13485, MDSAP, EU MDR, US FDA 21CFR, Canada SOR 98/282, Microsoft Office
Responsibilities
Prepare technical documents for regulatory submissions, maintain regulatory files and licenses, assess device complaints and adverse events, participate in audits and corrective actions, monitor regulatory updates and perform gap analyses
Seniority
Mid-level, hands-on IC