Head of Regulatory Affairs & Quality Assurance

Salary circa €130,000 + Benefits

Cure Talent are delighted to be partnered with an established medical device manufacturer & distributor specialising in diagnostic solutions for pathology and laboratory use, with a long-standing portfolio of IVD products supplied across European and international markets. Due to continued growth, they are now looking to appoint a Head of QA & RA to join their Quality & Regulatory team, based in Alphen aan den Rijn, South Holland, Netherlands.

This is a senior leadership position with responsibility for the quality assurance and regulatory affairs functions across the business. Reporting to the President, you will set and execute the quality and regulatory strategy, maintain and improve the QMS, and ensure ongoing compliance with relevant medical device and IVD regulations.

You will act as a key advisor to the Executive Team on quality, regulatory and compliance matters, including product registrations, post-market surveillance, vigilance, audit readiness and market access. Working closely with cross-functional teams and external partners, you will help shape product quality, support commercial goals, and ensure the business remains inspection-ready and compliant across its territories.

You will be an accomplished QA/RA leader with deep IVD or medical device experience, strong regulatory judgement and the confidence to influence at executive level. You will combine a strategic mindset with hands-on delivery, excellent stakeholder management and the ability to lead teams through change in a fast-moving international environment.

Role Responsibilities

• Lead the Quality Assurance and Regulatory Affairs function, maintaining a compliant QMS and driving continuous improvement across systems, processes and performance.
• Act as Management Representative and PRRC where applicable, ensuring the organisation meets its quality and economic operator obligations.
• Define and deliver regulatory strategy for EU IVDR, UK MDR, CH IvDo and other relevant international markets, supporting registrations and market access.
• Oversee post-market surveillance, vigilance, technical documentation and audit readiness, including interactions with Notified Bodies and regulators.
• Advise executive leadership and cross-functional teams on quality, regulatory risks, product compliance and business impacts, ensuring clear, risk-based decision-making.

Key requirements / What we look for

• Proven QA/RA leadership experience in IVD or medical devices.
• Proven management experience in an international business.
• Strong working knowledge of ISO 13485, EU IVDR, UK MDR 2002 and CH IvDo.
• Degree in Science, Quality Management, Regulatory Affairs or similar.
• Fluent English; audit and MEAI experience desirable.