QA/RA Lead – Global SaMD/IVD Diagnostics

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

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.