Quality Assurance Manager

Unity Partners on behalf of our Digital Health partner

We are currently seeking a driven QA/RA Manager for an innovative scale-up in the medical technology space. This role offers the opportunity to make a tangible impact in the fast-growing domain of remote patient monitoring and digital lifestyle interventions.

As QA/RA Manager, you will be responsible for maintaining and strengthening the company's QMS, ensuring compliance with relevant standards such as ISO 13485 and ISO 27001, and overseeing regulatory processes across product development, market access, and safety. You will play a vital role in aligning quality and regulatory efforts with the company's broader strategy for international growth and innovation.

You will act as the Management Representative for all quality-related matters, PRRC under the MDR and the primary point of contact for audits, incident reporting, CE mark submissions, and other external regulatory interactions.

Key Responsibilities

• Ensure regulatory compliance with ISO 13485, ISO 27001/NEN 7510, MDR (93/42/EEC), and maintain proper documentation throughout the QMS.
• Lead the transition to the 2022 ISO 27001 standard and align internal processes accordingly.
• Oversee CE Mark applications and manage technical documentation and market registrations.
• Conduct internal audits, manage CAPAs, and drive continuous improvement in risk and deviation management.
• Review and improve SOPs, regulatory documents, and clinical claims to ensure alignment with current standards.
• Ensure product approval and safety across the lifecycle, from development to market access.
• Define and monitor annual quality goals and support strategic regulatory expansion.

Your Profile

You are a proactive and analytical QA/RA professional with strong communication skills and a hands-on mindset. You bring:

• Several years of experience in QA/RA roles within the medical device industry.
• Deep knowledge of ISO 13485, ISO 27001/NEN 7510, ISO 9001, and MDR.
• Familiarity with UDI and interactions with notified bodies.
• Fluency in Dutch and English.
• (Bonus) Affinity with software development and usability engineering principles.

Organization & Offer

You will join a purpose-driven organization that blends innovation, digital health, and clinical excellence. The team is dynamic and multidisciplinary, offering a collaborative, informal, and fast-paced work environment. This is a full-time role offering the opportunity to shape QA/RA operations at both strategic and operational levels, room for personal development and growth beyond the scope of the role and a competitive salary and benefits package, in line with the high-impact nature of the role.

INTERESTED?

For more information or to apply directly, please contact Christian Steenkamp at (0) or via email at