Regulatory Affairs Medical Devices Officer
Core
Regulatory Affairs Officer specializing in medical devices, managing technical files, registrations, and compliance documentation for Biofarma Group's device portfolio.
Role type
Regulatory Affairs Officer (Medical Devices)
Builds
Regulatory compliance documentation and product registrations for medical devices
Domain
Medical Devices / Health & Beauty Care
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical device regulations (MDD 93/42, MDR 745/2017), Technical file preparation, Client regulatory request management, Product technical sheet creation, Regulatory change management, Health Ministry database registration, Packaging artwork regulatory review
Preferred skills
None stated
Technologies
None stated
Responsibilities
Drafting and updating technical files for medical devices in compliance with MDD and MDR regulations; Managing client requests regarding regulatory aspects; Handling documentation for client projects including Extra-EU registrations; Creating and updating product technical sheets for medical devices; Managing regulatory changes; Supervising registration activities with the Ministry of Health and CLV requests; Developing and managing labeling texts for medical devices; Conducting regulatory checks on primary and secondary packaging artworks
Seniority
Mid-level (3+ years experience)