Senior Regulatory & Quality Manager

Medella Life; München; Hybrid; EUR 75.000 - 90.000; Vollzeit

Zusammenfassung

A medical device company in Munich is looking for a Senior Regulatory & Quality Manager to ensure full regulatory compliance and effective quality oversight. This role primarily acts as the company's Person Responsible for Regulatory Compliance (PRRC) under EU MDR. Responsibilities include maintaining regulatory documentation, leading audits, and providing expert guidance to cross-functional teams. The ideal candidate will have a degree in life sciences or engineering, significant experience in regulatory affairs, and fluent German skills.

Qualifikationen

• 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.

Aufgaben

• Ensure regulatory compliance prior to product release and maintain technical documentation.
• Support cross-functional teams by providing regulatory and quality guidance.
• Oversee audits, inspections, and risk management activities.

Kenntnisse

Regulatory compliance expertise

Quality management skills

Leadership

Stakeholder management

Communication

Ausbildung

Degree in life sciences, engineering, or a related field

Jobbeschreibung

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.

Fluent German (Required) & Advanced English (Preferred)