Senior Regulatory & Quality Manager (Acting Primarily as PRRC) – Hybrid, Munich
Role Purpose
The Senior Regulatory & Quality Manager supports the company by ensuring full regulatory compliance and effective quality oversight. The role primarily acts as the company’s Person Responsible for Regulatory Compliance (PRRC) in accordance with EU MDR, providing strategic and operational leadership across regulatory and quality activities.
Key Responsibilities
PRRC & QMR Responsibility
* Act as the company’s Person Responsible for Regulatory Compliance (PRRC) under EU MDR and Quality Management Representative (QMR), ensuring regulatory compliance prior to product release, maintenance of technical documentation, fulfilment of post-market and vigilance obligations, and effectiveness of the Quality Management System. Serve as the main contact for authorities, notified bodies, and auditors, and report compliance and QMS performance to top management.
Regulatory & Quality Responsibilities
* Support the company’s business objectives by providing expert regulatory and quality guidance to cross-functional teams.
* Ensure the Quality Management System is implemented, maintained, and aligned with applicable regulatory and quality requirements (e.g. ISO 13485, EU MDR)
* Lead and support internal and external audits, inspections, and assessments.
* Oversee CAPAs, deviations, non-conformities, and risk management activities.
* Monitor regulatory changes and assess their impact on company processes, products, and market access.
* Develop, review, and maintain SOPs, regulatory submissions, and quality documentation.
* Deliver regulatory and quality training
Qualifications & Experience
* Degree in life sciences, engineering, or a related field.
* Significant senior-level experience in regulatory affairs and quality management within a regulated industry.
* Demonstrated experience acting as PRRC under EU MDR.
* In-depth knowledge of EU regulatory frameworks and applicable quality standards.
* Strong leadership, communication, and stakeholder management skills.
Please note: Fluent German (Required) & Advanced English (Preferred)