Head of Quality Assurance & Regulatory Affairs

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

Head of Quality Assurance & Regulatory Affairs

We are now looking for a Head of Quality Assurance & Regulatory Affairs to join our team in Leiden.

Full-time

BlinkLab Limited is a digital health company developing technology to make neurological and neurodevelopmental assessment more objective, accessible, and scalable. Our lead product, BlinkLab Dx1, is being developed as a smartphone-based diagnostic aid for autism assessment. It combines carefully controlled sensory stimulation, smartphone-based measurement, computer vision, and machine learning to measure reflexive responses that are difficult to capture in routine clinical practice. BlinkLab grew from a Princeton University startup into an ASX-listed public company (ASX:BB1) and today brings together an international team of neuroscientists, clinicians, engineers, machine learning specialists, and medical device professionals across the Netherlands, the US, and Australia.

We are now looking for a Head of Quality Assurance & Regulatory Affairs to join us in Leiden and help take BlinkLab through the next stage of its development.

This is much broader than a QMS maintenance role. You will join at a point where quality and regulatory affairs are deeply connected to the product itself. You will work directly with the people designing the software, developing the algorithms, running clinical studies, and preparing our products for regulatory review and commercial use. That means getting into the details when needed, understanding how the product works, asking difficult questions, translating regulations into practical engineering requirements, and finding solutions that are both compliant and workable for a fast-moving development team.

You will take day-to-day ownership of BlinkLab’s quality and regulatory affairs function, reporting initially to the Chief Quality and Regulatory Officer. You will have significant autonomy to shape how the function operates, define the processes and methods needed, and lead regulatory and quality activities across the company. Your immediate focus will be on the FDA pathway, followed by CE marking under the EU MDR.

What you’ll be doing:

You will lead and further develop our quality and regulatory activities, including:

• Maintaining and continuously improving our ISO 13485 Quality Management System and ensuring alignment with applicable FDA Quality Management System Regulation (QMSR) requirements;
• Leading regulatory strategy and submissions, with an immediate focus on the FDA pathway and subsequent CE marking under the EU MDR;
• Working closely with software, ML, clinical, and product teams on design controls and technical documentation;
• Ensuring appropriate application of software development lifecycle, usability, and cybersecurity requirements applicable to Software as a Medical Device;
• Preparing for and leading audits and inspections, and managing interactions with regulators, notified bodies, and external regulatory partners;
• Supporting supplier qualification, CAPA, nonconformances, complaints, and post-market activities;
• Helping teams turn regulatory requirements into processes that people can actually understand and use;
• Building and shaping the quality and regulatory function as BlinkLab moves from a development-stage company toward a commercial medical device organization.

And, because we are a small company, occasionally doing something that isn’t neatly described by your job title.

Who we’re looking for:

• We are looking for someone with strong medical device quality assurance and regulatory affairs expertise who takes a pragmatic, collaborative approach to compliance.
• You have significant hands-on experience with medical devices, ideally with Software as a Medical Device (SaMD) or other digital health products, and are comfortable operating independently.
• You have strong practical experience with ISO 13485, ISO 14971, and medical device design controls, together with a strong working knowledge of FDA and EU MDR requirements.
• Experience with Software as a Medical Device and working knowledge of IEC 62304 are highly relevant to this role. Experience with FDA 510(k) submissions, AI/ML-enabled medical devices, cybersecurity, or usability engineering would be particularly valuable.
• Just as importantly, you should enjoy working with engineers and scientists. We don’t need someone who simply tells a development team that something isn’t compliant. We need someone who can explain what good looks like and how we can get there together.

What it’s like to work at BlinkLab:

BlinkLab is still small enough that each person can make a visible difference. You won’t be several organizational layers removed from the technology or the decisions. You’ll work directly with the people building the product and with company leadership. We are scientifically driven, pragmatic, and ambitious. We take the responsibility of developing medical technology seriously, while avoiding processes that exist simply for the sake of process. Some problems will already have a procedure. Others will have a whiteboard.

If you like the idea of helping turn promising neuroscience into a regulated medical device and helping build the quality and regulatory organization needed to do it properly, we’d like to hear from you.

Not the right fit?

No worries: we've got more to offer. Check out our other open roles and find your place at BlinkLab.