Quality & Regulatory Affairs (m/w/d) Medizintechnik
Core
Head of Quality & Regulatory Affairs responsible for developing and maintaining the QMS and ensuring regulatory compliance for medical devices and software.
Role type
Senior IC Quality & Regulatory Affairs Manager
Builds
Medical devices and software for lung function diagnostics
Domain
Medical Technology / Regulatory Compliance
Required skills
ISO 13485, MDR, risk management, CAPA, change control, technical documentation, audit management, supplier evaluation
Preferred skills
Usability Engineering (IEC 62366-1), Software lifecycle (IEC 62304)
Technologies
ISO 13485, MDR, EN ISO 14971
Responsibilities
Develop and maintain QMS per ISO 13485; Ensure compliance with MDR and international regulations; Create and approve quality documentation (SOPs, manuals, risk docs); Coordinate international regulatory and quality activities; Manage operational QM tasks (incidents, changes, audits); Participate in product development; Analyze regulatory changes; Conduct internal/external audits; Handle CAPA and non-conformity processes.
Seniority
Senior, hands-on IC