QA/RA Director

Overview

We are seeking an experienced QA/RA Director to lead Quality and Regulatory activities for an established medical device manufacturer based in Germany. This is a key leadership position, responsible for ensuring compliance with international regulatory standards while driving continuous improvement across the Quality Management System.

Responsibilities

• Lead and develop the Quality and Regulatory Affairs teams, fostering a culture of quality and compliance across all operations
• Maintain and improve the Quality Management System (ISO 13485), ensuring compliance with EU MDR and other applicable global regulations
• Oversee regulatory submissions, technical documentation, and product registrations in the EU and international markets
• Act as primary contact with Notified Bodies, regulatory authorities, and external auditors
• Support internal audits, CAPA processes, risk management, and post-market surveillance activities
• Provide strategic input on new product development to ensure regulatory and quality considerations are built in from concept to launch
• Collaborate closely with cross-functional teams including R&D, Operations, and Clinical Affairs

Qualifications

• Degree in Engineering, Life Sciences, or related field (advanced degree preferred)
• 10+ years’ experience in Quality Assurance and Regulatory Affairs within the medical device industry
• Strong knowledge of ISO 13485, EU MDR, and international regulatory frameworks (e.g. FDA, MDSAP)
• Proven leadership experience managing quality and regulatory teams
• Excellent communication skills, with the ability to influence at all levels of the business
• Fluent in English; German proficiency preferred

Other

• Seniority level: Director
• Employment type: Full-time
• Job function: Quality Assurance
• Industries: Medical Equipment Manufacturing

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