Head of Quality Management and Regulatory Affairs | Biologe (m/w/d)
Funke Medical GmbH
Job Summary
This role seeks an ambitious Head of Quality Management and Regulatory Affairs (QM/RA) to join Funke Medical, a leading German manufacturer of high-quality, MDR-certified medical positioning systems. The successful candidate will be responsible for ensuring global product conformity and compliance with all regulatory and quality requirements, specifically acting as the Person Responsible for Regulatory Compliance (PRRC) under Article 15 MDR. Key daily tasks involve coordinating worldwide product approvals, creating and updating technical documentation according to MDR and ISO 13485, managing post-market surveillance activities, and leading internal and external audits. The position requires strong communication skills for interacting with authorities and Notified Bodies, a structured approach, and the ability to lead the continuous development of the Quality Management System while managing one direct report.
Required Skills
Education
Completed technical or scientific education/degree; Further training in Quality Management (e.g., Quality Management Representative or Auditor)
Experience
- Several years of experience in Regulatory Affairs and Quality Management for medical devices (Risk Class I)
- Professional experience in product registration with GKV (Statutory Health Insurance)
- Experience in continuous development of Quality Management Systems
Languages
Additional
- Must be able to serve as the Person Responsible for Regulatory Compliance (PRRC) according to Article 15 MDR; Position is primarily on-site.