Quality Management & Regulatory Affairs Manager – Medical Devices (m/f/d)
Core
Ensure medical device portfolio meets quality and regulatory standards, manage QM processes, and maintain audit readiness.
Role type
Manager, Quality Management & Regulatory Affairs
Builds
Medical device portfolio compliance and quality systems
Domain
Medical Devices / Regulatory Affairs
Required skills
Change control management, complaint handling, CAPA, internal audit execution, ISO 13485 knowledge, MDR knowledge, technical documentation maintenance, vigilance activities
Preferred skills
Auditor qualification, eQMS experience, RA database experience, dermatology background, medicinal products background, cosmetics background, food supplements background
Technologies
ISO 13485, MDR, eQMS
Responsibilities
Operational management of change control, complaint handling, and CAPA; Preparation and execution of internal audits; Maintenance and development of the quality management system; Qualified regulatory support for the medical device portfolio; Contribution to technical documentation updates; Support with ongoing vigilance activities
Seniority
Manager, hands-on IC