Regulatory Compliance Officer

Hartwig Medical Foundation; Amsterdam; Hybrid; EUR 70,000 - 95,000; Full time

Benefits offered by this job

26 vacation days per year

Two-thirds pension contribution

Hybrid working environment

Generous office lunch

Access to professional development opportunities

Job summary

A non-profit organization dedicated to cancer care is looking for a Regulatory Compliance Officer in Amsterdam. This role entails overseeing IVD/MD compliance for software products and data-driven tools while collaborating with various stakeholders. Applicants should have a degree in life sciences or a related field and 5+ years in regulatory affairs, particularly IVDR/MDR. The position offers a competitive salary, flexible working hours, and opportunities for professional development.

Qualifications

• 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.
• Basic knowledge of software products and development
• Strong communication skills in English (Dutch a plus)

Responsibilities

• Lead IVD/MD compliance for software products and tools.
• Coordinate the organization’s accreditation strategy.
• Oversee post-market surveillance and manage regulatory communications.
• Oversee post-market surveillance (PMS) including PER/PSUR and risk updates
• Serve as main contact for regulatory authorities and Notified Bodies
• Educate colleagues on IVDR/MDR and ISO13485 requirements and advise on regulatory strategy

Skills

IVDR/MDR compliance

Regulatory affairs

Quality management

Strong communication

Software knowledge

Education

Degree in life sciences, engineering, or related field

Engineering degree

Bioinformatics degree

Tools

QMS software

Regulatory databases

Job description

Regulatory Compliance Officer

Hartwig Medical Foundation

We seek an experienced Regulatory Compliance Officer to take ownership of IVD/MD compliance for our software products and data‑driven tools. You will join a small, dedicated team committed to delivering the best molecular diagnostics for patients with cancer. Your autonomy and expertise will directly impact our product lifecycle and regulatory strategy.

Mission: Contribute to improving care for patients with cancer by ensuring regulatory compliance and supporting evidence‑based decision making.

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.

Your Profile: You are driven by solving complex problems and making an impact in fast‑paced environments. Proactive, solution‑oriented, and collaborative, you enjoy working with software developers and exploring data analytics in life sciences.

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).

Why us?

• Meaningful role (32–40 hours per week) in a mission‑driven, non‑profit organization.
• 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.
• €0.23 per kilometre for commuting.
• 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 Academy for professional development, growth, and certification opportunities.

Apply! If this role excites you, click the application button or send an email to [e-mail] with your CV and cover letter. The application process includes two interviews, a motivation assessment, and a reference check.

About Us: 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 develop comprehensive DNA testing to help hospitals analyze tumors with precision and support clinicians in making informed treatment decisions. Our rich knowledge base on patients, tumors, and treatment outcomes drives breakthroughs for future care. We collaborate closely with hospitals, researchers, and partners across the Netherlands to lower barriers to personalized cancer care. Join our multidisciplinary team of experts—including medical professionals, analysts, bioinformaticians, and software developers—to make a real impact on patient care.

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