Quality Assurance Specialist

Unity Partners on behalf of our HealthTech partner

We are currently seeking a QARA Specialist for a fast-growing and purpose-driven HealthTech scale-up. In this role, you'll take ownership of the company's compliance operations and quality frameworks, working hands-on while collaborating closely with management, product, tech, and medical experts. You'll have a direct impact on regulatory success, business continuity, and patient safety.

This is a unique opportunity for a proactive compliance professional to become the central figure in maintaining and advancing the company's quality and information security frameworks. You'll oversee both ISO 27001 / NEN 7510 and support the roadmap towards ISO 13485 and CE marking in collaboration with external MDR specialists. You'll get the chance to build your own team and enjoy operational execution at the same time.

Key Responsibilities

• Maintain and improve compliance with ISO 27001 and NEN 7510 standards, including audits, risk assessments, and CAPAs
• Develop and implement the QMS in preparation for ISO 13485 certification
• Lead CE-marking activities in collaboration with external MDR specialists
• Manage and update technical documentation, including post-market surveillance obligations
• Act as primary liaison for regulatory bodies and manage compliance incident reporting
• Conduct internal audits and risk assessments across departments
• Drive awareness and training around compliance and quality culture within the organization
• Ensure up-to-date registrations and communications with relevant authorities

Your Profile

• 5+ years of experience in a QA, RA, or compliance role within healthcare or HealthTech
• Proven experience with ISO 27001 and/or NEN 7510 frameworks
• Familiarity with ISO 13485 and MDR (CE-marking processes) is a strong advantage
• Hands-on, structured, and proactive mindset with strong ownership mentality
• Fluent in Dutch or English (both spoken and written)
• Strong communicator who enjoys collaborating with multidisciplinary teams
• Comfortable working in a solo role within a dynamic, fast-moving environment

Organization & Offer

You'll join a mission-driven digital health innovator shaping the future of patient care. The company is scaling rapidly and offers a flat, informal culture where initiative and responsibility are encouraged. You can expect a competitive salary, personal development budget, and the opportunity to build a best-in-class compliance function from the ground up.

INTERESTED?

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