Senior Compliance Manager – Quality & Regulatory Affairs / QMB ISO 13485 (m/w/d)
Core
Senior Compliance Manager responsible for Quality Management System (QMS) and regulatory compliance for medical devices and digital health apps.
Role type
Senior IC compliance manager (medical devices/regulatory)
Builds
Medical device products (app and hardware) compliant with MDR, ISO 13485, and DiGA regulations
Domain
Digital Health / Medical Devices / Regulatory Affairs
Required skills
ISO 13485, MDR, DiGA, ISO 27001, audit preparation and execution, technical documentation (DHF/DMR), supplier management, regulatory change analysis
Preferred skills
PRRC experience, SaMD knowledge, BSI certification experience, Jira/Confluence
Technologies
MDR, ISO 13485, DiGA, ISO 27001, BSI, Atlassian, HubSpot, Google
Responsibilities
Oversee QMS and regulatory compliance, prepare for and conduct audits, manage technical documentation, review release documentation, monitor post-market surveillance, evaluate software suppliers, analyze regulatory changes
Seniority
Senior, hands-on IC