As 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.