Regulatory Specialist
Core
Ensure CE marking compliance for medical devices on the European market and manage post-market surveillance systems.
Role type
Regulatory Specialist (Medical Devices)
Builds
Technical files, product labels, and regulatory compliance documentation for Medline's medical devices.
Domain
Medical Devices / Healthcare / European Regulatory Affairs
Required skills
Medical device regulations (MDR 2017/745, ISO 13485), Technical file preparation, Label review and approval, Post-market surveillance coordination, Regulatory monitoring
Preferred skills
PPE, cosmetics, and biocides regulations knowledge
Technologies
MDR 2017/745, ISO 13485
Responsibilities
Ensure regulatory compliance of Medline products sold or distributed in Europe; Review and approve product labels per EU requirements; Participate in the creation and update of technical files; Act as the primary contact for commercial teams on regulatory matters; Participate in regulatory monitoring; Participate in product registrations
Seniority
Mid-level Specialist