Overview
Head of Quality and Regulatory Affairs Jobs in Helsinki, Uusimaa, Finland at Ounas Health
Title: Head of Quality and Regulatory Affairs
Company: Ounas Health
Location: Helsinki, Uusimaa, Finland
Giving Clinicians the Full Picture
Ounas Health is a Finnish health-tech startup building the tools clinicians need to actually see what’s going on with their patients — not fragments spread across ten systems, but one coherent view: imaging, EMR data, biometrics, clinical guidelines, all in one view. We’re starting in eye care and building towards the rest of healthcare.
We’re less than a year old, funded, and moving fast. Small team, high trust, real ownership from day one. Our founders have built and sold health-tech companies before, and they’re putting that experience to work here.
The Role
We are looking for our first dedicated quality and regulatory professional to build and lead the quality and regulatory capability at Ounas Health.
As the Head of Quality and Regulatory Affairs your purpose is to enable Ounas Health to enter and remain in its target markets — currently the EU and the UK — safely, compliantly, and as efficiently as possible. This includes establishing a practical and scalable quality management system, guiding regulatory strategy, and embedding regulatory requirements into everyday product development.
Ounas develops both medical device and non-medical software, often within the same teams and development flow. One of the central challenges of the role is to create a way of working that applies the full regulatory discipline where it is required and stays out of the way where it is not. We do not want two disconnected development models, nor do we want unnecessary medical-device processes applied across everything we build.
This is a Head role because you will own the capability and have direct access to company management — not because you will inherit a ready-made function or a large team. At least initially, this is a highly hands-on position: you will define the approach, create and maintain documentation, support product teams, prepare audits, and work directly with external regulatory parties.
We want regulatory requirements to be built into how products are developed, so that compliance becomes a natural outcome of normal work rather than a separate activity. Done badly, quality management becomes bureaucracy. Done well, it helps the company make sound decisions, develop safer products, and demonstrate why those products can be trusted.
At our current stage, the goal is not theoretical perfection. It is a sufficient, effective, and scalable system that materially supports safety, compliance, and market access.
What Head of Quality & Regulatory Affairs Will Do at Ounas Health
- Build, maintain, and continuously improve our quality management system in accordance with ISO 13485 and the EU MDR.
- Establish pragmatic quality and regulatory practices that integrate into product development and scale with the company.
- Own our EU and UK regulatory strategy, including product qualification and classification, conformity assessment routes, and cooperation with external regulatory parties.
- Ensure that risk management, technical documentation, clinical evaluation, usability engineering, and post-market activities are appropriately planned and completed together with the relevant teams.
- Lead internal and external audits and manage quality and regulatory cooperation with authorities, notified bodies, certification bodies, and other external partners.
- Act as Ounas Health’s ISO 13485 management representative.
- Act as the company’s PRRC if you meet the MDR qualification requirements or coordinate the function with an external PRRC.
It is worth stating openly that we are an early-stage company. The role comes with considerable autonomy and influence, but also ambiguity, changing priorities, limited resources, and practical work outside neatly defined boundaries. You will need to distinguish between what is mandatory, what materially improves safety or compliance, and what can wait.
What We Are Looking For
We are looking for someone with:
- Strong practical knowledge of the EU MDR and ISO 13485 in a medical software environment.
- Experience building, maintaining, or substantially developing a medical device quality management system.
- Experience translating regulatory requirements into workable practices for product and software development teams.
- The ability to take ownership of regulatory strategy and guide technical documentation for medical device software.
- Sound judgement in balancing compliance, product safety, business needs, and limited resources.
Our team already has experience building ISO 13485-compliant quality management systems and developing medical device software. You will therefore not be starting without internal knowledge or support. We are looking for someone to take dedicated ownership of this area, deepen our capability, and turn that experience into a coherent and scalable way of working.
Any of the following would help you get started, but we do not expect one person to have them all:
- Qualification to act as PRRC under MDR Article 15.
- Experience with relevant software, risk management, usability, information security, or AI-related standards and regulation.
- Experience with clinical evaluation, post-market activities, or notified body and certification audits.
- Familiarity with the UK medical device market.
- Experience working in a startup or another environment where processes must remain proportionate and practical.
You do not need to arrive with every answer. You do need to be comfortable taking responsibility for regulatory judgement, explaining your reasoning clearly, and building structure in an organisation where many things are still being defined.
This role is likely to suit someone who has already worked independently with medical device quality and regulatory matters and now wants broader ownership. It may also suit an experienced quality or regulatory lead who wants to build a system from the ground up instead of maintaining one designed for a much larger organisation.
Practicalities
This is a full-time position. We prefer the candidate to start as soon as possible. We are prepared for the monthly salary to land somewhere between 5000€ – 6000€ depending on your background. In addition, eligible team members can join our stock option program so you will have a chance to actually own a piece of what we are building.
We have offices in Helsinki, at Mäkelänkatu 2, and in Oulu, at Hallituskatu 13–19. At the current stage of the company, we find it useful to work at the office together on several days of the week —especially when we plan, solve problems, and create new ways of working. However, we also work remotely when we feel like it. We do not offer relocation or immigration services.
The role reports to CEO Ville and has direct access to the management team in matters concerning quality, product safety, regulatory compliance, market access, and release readiness. At Ounas, Co-Founder Anssi makes sure our people are happy and takes care of every HR matter.
Apply
Send your application and CV to [email protected] by Sunday 23th, 2026. Please include:
- A short description of your relevant experience
- Why this role and Ounas Health interest you
- Your preferred starting date
- Your salary expectation
- Links to relevant work, publications, projects, or professional profiles, where applicable
Applications will be reviewed during the application period, and the position may be filled as soon as a suitable candidate is found. Applications are accepted only via [email protected], please don’t send applications via personal channels to our team.
For further information, contact:
- Elisa Laurila, Co-founder
- [email protected]
- +358-40-7093680
You may contact Elisa on:
- Friday Aug 14th, at 14:00-15:00
- Monday Aug 17th, at 13:00-14:00
Please respect the allocated contact times – our team members might not be able to reply on inqueries through personal channels outside the contact times.
If this position is not for you, you can send an open application to [email protected]!
