QA/RA Lead

Hartwig Medical Foundation; Amsterdam; On-site; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Competitive salary and benefits

26 vacation days

Pension plan (Hartwig contributions)

Office lunches Tue/Thu, drinks Fri, &s

Annual team events

International scope

Job summary

Hartwig Medical Foundation seeks a QA/RA Lead to own quality and regulatory compliance across its business units. You will lead a cross-functional quality team, embed quality into the product lifecycle, and drive audits, CAPAs, and regulatory submissions.

You will manage the integrated QMS, oversee EU MDR/IVDR strategy for SaMD/IVD software, and maintain ISO 17025/Gx transitions. Strong leadership and hands-on involvement are required.

Qualifications

• Bachelor’s/Master’s in Life Sciences, Biomedical Engineering, Bioinformatics, or related field.
• 10+ years in QA/RA within medical devices or IVD, with hands-on Notified Body audit experience (ISO 13485, MDR or IVDR).
• Experience leading quality teams in a regulated environment; strong knowledge of ISO 14971 and IEC 62304.
• Excellent English communication skills; eligible to work in the Netherlands.

Responsibilities

• Own and continuously strengthen the integrated QMS across the Netherlands, Australia, and Canada, including audits and management reviews.
• Lead regulatory strategy for SaMD/IVD software under EU MDR and IVDR, including Technical Documentation and PMS/PSURs.
• Monitor evolving standards and support regulatory submissions in Australia (TGA) and Canada (Health Canada).
• Lead and develop a Quality team of 3–6 professionals, manage the QA budget, and report on quality KPIs and risk metrics.

Skills

QA/RA leadership

Audit experience

ISO 14971

IEC 62304

Regulatory strategy

Cross-functional leadership

Education

Bachelor’s/Master’s in Life Sciences or related

Job description

Would you like to safeguard quality and regulatory compliance at the forefront of cancer diagnostics?
As Quality Assurance/Regulatory Affairs (QA/RA) Lead you will be the accountable owner of quality and regulatory compliance across the Business Units of Hartwig Medical Foundation organization. Reporting directly to the Managing Director, you will lead a cross-functional Quality team and work in close partnership with the Business Unit leads to embed quality into every stage of the product and service lifecycle. You take a proportionate approach: applying quality standards and rigour where they matter most, while staying pragmatic and result-oriented elsewhere. While you set the strategic direction, you are equally comfortable rolling up your sleeves reviewing a technical file yourself, drafting a CAPA, or joining an audit conversation directly, rather than only delegating.

What You Will Do

You will own and continuously strengthen our integrated quality and regulatory framework, while staying closely involved in the day-to-day work of your team:

• Own and continuously improve the integrated QMS (ISO 13485, ISO 15189, ISO 27001) across the Netherlands, Australia, and Canada, including audits and management reviews.
• Lead regulatory strategy for SaMD/IVD software under EU MDR and IVDR, including Technical Documentation and post-market surveillance (PMS, PSURs, SSP).
• Monitor evolving standards (IEC 62304, IEC 62366, ISO 14971) and support regulatory submissions in Australia (TGA) and Canada (Health Canada).
• Maintain the ISO 17025 lab QMS and support the transition to ISO 15189, working closely with Laboratory Operations on validation and equipment qualification.
• Lead and develop a Quality team of 3-6 professionals, manage the QA budget, and report on quality KPIs and risk metrics.
• Champion a culture of quality through mentoring, training, and process improvement across the organization.

What You Bring

You are an experienced QA/RA professional who combines regulatory depth with hands‑on leadership:

• Bachelor’s/Master’s in Life Sciences, Biomedical Engineering, Bioinformatics, or related field.
• 10+ years in QA/RA within medical devices or IVD, with hands‑on Notified Body audit experience (ISO 13485, MDR or IVDR).
• Experience leading quality teams in a regulated environment; strong knowledge of ISO 14971 and IEC 62304.
• Excellent English communication skills; eligible to work in the Netherlands.
• A hands‑on, pragmatic, proportionate approach to quality.
• Nice to have: ISO 15189 lab experience, genomics/NGS/oncology background, TGA or Health Canada submission experience, Dutch proficiency.

What We Offer

• A pivotal leadership role (32 – 40 hrs/week) at a mission‑driven, non‑profit organization.
• Work at the intersection of life sciences, data, and technology, with international scope.
• Competitive salary and benefits.
• 26 vacation days (based on full‑time employment).
• A pension plan to which Hartwig Medical Foundation contributes two‑thirds of the premium.
• Complimentary office lunches on Tuesdays and Thursdays, Friday afternoon drinks, and annual team events.

By using WGS, we took a step forward in molecular diagnostics in our department from the analysis of less than 100 genes to approximately 20,000 genes per patient. This provides an enormous amount of valuable information, not only for the patient of today, but also for the patient of the future.

Want to know more about the complete DNA test?