Director Quality Assurance & Regulatory Affairs

The organisation

Our client is a global operating organisation in the medical devices industry, present in countries all over the world. This organisation is constantly focusing on developing high quality and innovative products to improve and simplify healthcare.

The position

As a Director Quality Assurance & Regulatory Affairs, you develop and guide the quality and regulatory strategy of the organisation. With your extensive experience in leading quality and regulatory teams, your people management skills, and your thorough knowledge of international regulatory compliancy, you will have a key role in further developing the international growth of the company.

Tasks & responsibilities

• Development and execution of QA/RA strategy
• Management of the QA/QC/RA departments
• Maintenance and improvement of the QMS
• CAPA management
• Quality improvement projects
• MDD/MDR readiness
• Management of pre and post marker related regulatory affairs
• Leading internal/external audits
• Requirements
• Bachelor or Master preferably in a technical field
• 8+ years experience and a proven track record in QA/RA management in the medical devices industry
• Strong negotiation and mediation skills to internal and external stakeholders such as authorities, notified bodies, management and suppliers
• Extensive knowledge of international regulatory requirements and legislation (ISO13485, FDA, JPAL, CMDCAS etc.)
• Excellent communication and people managent skills
• Strong experience and network regarding key opinion leaders

Interested?

You are invited to apply for this position by following the link below. For more information, please contact Rick Venneman, Senior Consultant, at +31 (0)23 754 86 60 or +31(0)6 40 91 64 03.