Chief QA & Regulatory Lead – SaMD MedTech

BlinkLab Limited (ASX:BB1); Leiden; On-site; EUR 120,000 - 180,000; Full time

Job summary

BlinkLab Limited in Leiden is seeking a Head of Quality Assurance & Regulatory Affairs to lead our quality and regulatory activities as we move from development toward commercial medical devices.

You will own ISO 13485, FDA QMSR, and EU MDR readiness, collaborate with software and clinical teams, prepare regulatory submissions, audits, and build scalable processes for fast-moving product teams.

Qualifications

• Significant hands-on experience with medical devices, SaMD or digital health.
• Strong knowledge of ISO 13485, ISO 14971, and design controls.
• Familiar with FDA and EU MDR requirements and 510(k) submissions.

Responsibilities

• Lead and develop quality and regulatory activities.
• Maintain ISO 13485 QMS and FDA QMSR alignment.
• Lead regulatory strategy and submissions (FDA first, CE later).
• Collaborate with software, ML, clinical, and product teams.
• Apply software dev lifecycle, usability, and cybersecurity rules for SaMD.
• Prepare for audits and coordinate with regulators and notified bodies.
• Turn regulatory requirements into actionable processes.

Skills

Quality assurance

Regulatory affairs

SaMD

Medical devices

FDA compliance

EU MDR

ISO 13485

ISO 14971

Design controls

Cybersecurity

Usability engineering

Job description

BlinkLab Limited in Leiden is seeking a Head of Quality Assurance & Regulatory Affairs to lead our quality and regulatory activities as we move from development toward commercial medical devices.

You will own ISO 13485, FDA QMSR, and EU MDR readiness, collaborate with software and clinical teams, prepare regulatory submissions, audits, and build scalable processes for fast-moving product teams.