Your work opens markets. Literally.
In most RA roles at larger organisations, you're one of many managing a slice of the compliance puzzle. Here, you lead. You own the regulatory strategy for Rest of World markets — new countries, new submissions, new approvals — for a growing medical device company whose products are already used on four continents.
This is a role for someone who knows their way around MDR, CE marking and international registrations, and is ready to do more than maintain what's already there.
What you'll do
As RA Officer within a lean Quality & Regulatory Affairs team, you'll take the lead on regulatory submissions and approvals across RoW markets (excluding MDSAP). You'll prepare and manage technical dossiers, track submission timelines, assess product changes for regulatory impact, and review labelling and marketing materials for compliance. You'll support the setup of new territories — appointing distributors, coordinating local RA agents — and act as a coach to junior team members or external consultants where needed. Final regulatory decisions rest with the Director of Regulatory Affairs; everything leading up to those decisions is yours to drive.
What you bring
Msc, BSc or equivalent, with at least 5 years of Regulatory Affairs experience in medical devices- Solid experience with CE marking and high-risk device classifications
- Proven track record with worldwide registrations and RoW submissions
- Strong knowledge of MDR, MDD (Annex II), ISO 13485:2016 and relevant ISO standards
- Experience working with Notified Bodies, Competent Authorities and global Health Authorities
- Independent, decisive, and comfortable navigating ambiguity
- Based in the Netherlands
What's on offer
A full-time position at an international, fast-growing medtech company in the Utrecht area. You'll work in a small, expert team where your contributions are visible and your impact is real. Competitive salary, solid benefits, and genuine opportunities to grow alongside a company that's scaling fast — both commercially and geographically.
Ready to put your name on the map — in more ways than one?
Click Apply and we'll be in touch quickly.
