R&D specialist Cryogenic OTC medical devices

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Join Our Transformative Team: Shape the Future of OTC Medical Devices!

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This is not a role where you “support.”

This is a role where you decide what reaches the market.

At Pronova Laboratories, you work on medical self-care products that people actually use, not concepts that disappear in a drawer. One of our flagship products, Forwarts, is already an international success. Good. That’s the starting point, not the finish line. You make these products better, smarter, and stronger. At the same time, you help build what comes next.

You are not on the sidelines here. You are at the center of innovation, regulation, and market reality.

What you really do here

You take ownership. Of products, of projects, of decisions.

1. Life-cycle management of an international OTC product

You safeguard quality, effectiveness, and market position. You translate scientific insights, market feedback, and new legislation into concrete improvements. You initiate and lead clinical development and PMCF activities together with Quality and Regulatory.

2. New products that actually reach the market

You spot trends in OTC medical devices and turn them into real products, not slides. You define requirements, design controls, and steer development with Business Development and external partners, from idea to CE-marked device.

3. Project lead in a complex environment

R&D, Regulatory Affairs, Marketing, manufacturing partners, you connect it all. You drive planning, decisions, and progress. No meetings without outcomes. No projects without ownership.

4. Compliance without grey areas

You build and maintain technical documentation under MDR and our QMS. You translate requirements into verification and validation studies, write protocols, analyze data, assess suppliers, and document everything properly. This is not box-ticking — this is substance.

Why this is not a standard role

• You work on CE-certified medical devices , not marketing products
• You operate at the intersection of science, development, and regulation
• You get the freedom to shape new product concepts
• You work in a small, direct team where decisions are fast and responsibility is real
• You work from our office in Muiden, right where things happen

What we’re looking for in you

You don’t just have knowledge. You take the lead.

• MSc in biochemical engineering, biomedical engineering, medical biology, biotechnology, industrial design, or similar
• 4 years experience in a R&D position, preferably in medical device industry
• Experience with MDR compliance
• Knowledge and/er experience with MDR (EU 2017/745), ISO 13485, ISO 14971, preferably also 21 CFR 820
• Experience with clinical evaluations (MEDDEV 2.7.1 rev 4) and Clinical Investigations (ISO 14155:2011) is a strong plus
• Strong writing skills, analytical mindset, structured way of working
• Pro-active and adaptive attitud
• Ability to switch between detail and big-picture thinking
• Strong verbal and written communication skills in English, preferably also Dutch.

who this role fits perfectly

Someone who is done working on just a small piece of the puzzle.

Someone who wants to build products that end up on shelves worldwide.

Someone who values substance, responsibility, and impact over just a nice job title.

feel this is you?

Explore our product portfolio and don’t send a standard motivation letter.

Show us how you would shape this role and where you would make the difference.

Mail [email protected] and surprise us.