Director Quality Assurance & Regulatory Affairs EMEA

Company profile

Director Quality Assurance & Regulatory Affairs EMEA Wanted! Lead the European Quality & Regulatory Affairs team to ensure unparalleled product quality and compliance across EMEA. Drive strategic initiatives, manage budgets, and foster a culture of excellence that safeguards patient safety. Your expertise will be pivotal in maintaining the organisation commitment to the highest international standards for all our products.

Job profile

• Provide leadership, QA/RA support, and strategic direction to international QA/RA teams.
• Serve as Deputy Management Representative and PRRC Contact for the EMEA organisation.
• Manage QMS for manufacturing, warehouse, and distribution sites in Europe/UK.
• Ensure European sterilization activities comply with quality and regulatory requirements.
• Collaborate with management on strategic business plans and QARA structure for the EU organisation.
• Set QA/RA priorities, objectives, and develop/implement compliant procedures.
• Harmonize QMS with worldwide QA/RA teams.
• Support new product/material/source development, approval, and launch, ensuring design control compliance.
• Coordinate validation of new components for Custom Surgical Packs.
• Identify and implement process improvements.
• Coordinate with US RA for technical file creation/maintenance and notified body submissions.
• Obtain required Quality/EC Certificates.
• Ensure product registration with Competent Authorities in relevant countries.
• Coordinate post-market surveillance, handle complaints, recalls, and adverse events.
• Provide guidance, mentoring, and coaching to QA/RA teams.
• Deliver performance feedback, develop employees, and recognize achievements.
• Respond to customer/tender-related technical, quality, or regulatory questions.
• Represent the organisation at industry meetings and working groups on medical device standards.

Requirements

• University degree required (Engineering/Sciences preferred).
• 7-10 years of experience in Quality Assurance and Regulatory Affairs within the Medical Device industry.
• Excellent knowledge of ISO 13485, MDR 2017/745, MDD 93/42/EEC, and related regulations.
• Management experience with a proven ability to develop and lead a highly competent team.
• Proven ability to collaborate effectively across functional departments.
• Excellent written and oral communication skills; fluent in English and French.
• Process Improvement/Lean Six Sigma training is a plus.
• You live in the Utrecht Area.

Offer

Our target salary is €120K per year. The secondary employment benefits are excellent, and we would gladly provide further details during a personal interview.

What's next? Within four working days, we will let you know if you are eligible for the position. We will schedule an introductory meeting, either digitally or in person. In this meeting, we will inform you as fully as possible about the vacancy, the company, and the next steps in the procedure. In consultation with you, we will introduce you to our client and continue to guide you throughout the application process. The Independent Recruiters Group has a large team of specialized recruiters. Each recruiter has a very strong focus on their own field. This makes them the ideal sparring partner for both the candidate and the client.