Chief Quality & Regulatory Lead, SaMD (FDA & CE)

BlinkLab Limited; Leiden; Remote; EUR 120,000 - 180,000; Full time

Job summary

BlinkLab Limited in Leiden is seeking a Head of Quality Assurance & Regulatory Affairs to build and lead the quality and regulatory function as BlinkLab advances toward commercial medical devices.

You will own the QMS and regulatory strategy, collaborating with software, ML, clinical and product teams to translate regulations into practical engineering requirements and ensure strong, scalable compliance.

Qualifications

• Hands-on medical device QA and regulatory expertise.
• Experience with SaMD or digital health products.
• Strong knowledge of ISO 13485, ISO 14971, FDA and EU MDR.
• Experience with FDA 510(k) submissions, IEC 62304, cybersecurity, usability.
• Ability to translate regulations into practical engineering requirements.
• Collaborative work with engineers and scientists.

Responsibilities

• Maintain and improve ISO 13485 QMS and align with FDA QMSR.
• Lead regulatory strategy and submissions (FDA pathway, EU MDR CE marking).
• Work with software, ML, clinical and product teams on design controls and docs.
• Ensure software lifecycle, usability and cybersecurity requirements for SaMD.
• Prepare for audits and lead regulator interactions and audits.
• Support supplier qualification, CAPA, nonconformances and post-market activities.
• Turn regulatory requirements into actionable processes.
• Shape the function as BlinkLab grows toward a commercial medical device.

Skills

Regulatory affairs

Quality management

Cross-functional collaboration

SaMD knowledge

Education

ISO 13485 knowledge

ISO 14971 knowledge

IEC 62304 knowledge

FDA regulatory knowledge

EU MDR knowledge

Job description

BlinkLab Limited in Leiden is seeking a Head of Quality Assurance & Regulatory Affairs to build and lead the quality and regulatory function as BlinkLab advances toward commercial medical devices.

You will own the QMS and regulatory strategy, collaborating with software, ML, clinical and product teams to translate regulations into practical engineering requirements and ensure strong, scalable compliance.