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Regulatory Compliance Officer

Do you want to contribute to our mission of improving care for patients with cancer?

At Hartwig Medical Foundation, we are looking for an experienced Regulatory Compliance Officer who will take ownership of IVD/MD compliance for our software products and data-driven tools. You will join our small, dedicated team committed to delivering the best molecular diagnostics for patients with cancer, today and in the future. With short lines of communication and a wide variety of responsibilities, you can apply your expertise where it truly matters. You will have the autonomy to take ownership and work independently, while collaborating with other disciplines. This is your opportunity to make a direct impact as a senior Regulatory Compliance Officer within an organization with an important mission.

Your Role

Hartwig Medical Foundation contributes to building a learning healthcare system by analyzing molecular and clinical data to support personalized clinical decision-making, using our in-house developed software. In this role, you will ensure that our IVD/MD products meet regulatory and quality standards throughout their lifecycle. You will guide products from design to market release from regulatory perspective, coordinate risk management, oversee post-market surveillance, and serve as the main point of contact for regulatory authorities. In addition, you will help align accreditation strategies, educate colleagues, and advise management on regulatory matters.

Key Responsibilities:

• Lead IVD/MD compliance for software products and tools, including the creation and maintenance of technical documentation for new products and version releases.
• Coordinate and align the organization's accreditation strategy and implementation plans with international quality requirements of our clients and product users.
• Coordinate risk management processes and ensure general safety and performance requirements are translated into verifiable design criteria.
• Oversee post-market surveillance (PMS), including Performance Evaluation Reports (PER), Periodic Safety Update Reports (PSUR), risk analysis updates, and reporting obligations to Competent Authorities and Notified Bodies.
• Serve as the main point of contact for regulatory authorities and Notified Bodies and work closely with the Quality Manager to align regulatory requirements with QMS processes.
• Educate colleagues on IVDR/MDR and ISO13485 requirements and advise management on regulatory strategy and compliance matters.

What We Offer

• A meaningful role (32-40 hours per week) in a mission-driven, non-profit organization.
• A competitive salary.
• 26 vacation days per year (full-time).
• Hartwig contributes two-thirds to your pension.
• Hybrid working environment, combining office presence with remote work.
• Generous office lunch on Tuesdays and Thursdays, Friday drinks and annual company events.
• A dynamic, multidisciplinary team with an informal, open culture.
• Access to the Hartwig for professional development, growth, and certification opportunities.

About You

Are you driven by solving complex problems and making an impact? You can work effectively in fast-paced environments while keeping sight of the big picture. You are proactive, solution-oriented, and enjoy collaborating across teams. You're excited to work directly with software developers and explore data analytics in life sciences. No prior experience in genomics or cancer? No problem - this role allows you to gain deep expertise while contributing to meaningful projects.

Your background includes:

• Degree in life sciences, engineering, bioinformatics, or a related scientific field.
• 5+ years in regulatory affairs or quality management, including 2+ years in IVDR/MDR.
• Solid understanding of IVDR/MDR regulations.
• Basic knowledge of software products and development processes.
• Strong communication skills in English (Dutch is a plus).

Apply!

If this role excites you, we would love to hear from you. Please send your CV and cover letter to .

About Us

At Hartwig Medical Foundation, every day we work with one clear goal: to ensure that every patient with cancer receives the treatment best suited to their unique situation. We achieve this by developing comprehensive DNA testing that helps hospitals analyze tumors with precision and supports clinicians in making informed treatment decisions. At the same time, we are building a rich knowledge base on patients, tumors, and treatment outcomes, so that the care delivered today contributes to the breakthroughs of tomorrow.

Location: Science Park 408, 1098 XH, Amsterdam, Netherlands

Co-founder Missie Tumor Onbekend ('Mission Tumor Unknown')

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