5 beste vacatures voor de functie van quality manager in soesterberg (nieuwe medewerkers gezocht)

Regulatory Affairs Officer — Medical Devices
RnB Consultancy —Utrecht
- Fulltime
- Bachelor
Snel solliciteren
Risk Specialist Issue, Incident and Quality Management
ASN Bank —Utrecht
- € 4.552,48 - € 6.069,97 per maand
- Fulltime
- Analytisch vermogen
- Bankieren
- Reiskostenvergoeding
Warranty Engineer
Stoneridge —Barneveld
- Fulltime
- Engineering
- Analytisch vermogen
- Presentatievaardigheden
- Reiskostenvergoeding
Supplier Dev Engineer
Stoneridge —Barneveld
- Fulltime
- Engineering
- Engels
- Bachelor
QA Engineer Logistics (Fixed-term, 12 months)
Getinge Netherlands B.V. —Hilversum
- Microsoft Word
- Microsoft Excel
- Engels
1 dag

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Regulatory Affairs Officer — Medical Devices

RnB Consultancy
Utrecht

Snel solliciteren

Vacaturegegevens

Fulltime

Kwalificaties

Bachelor

Volledige vacaturetekst

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.

Snel solliciteren

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quality manager vacatures in soesterberg

Regulatory Affairs Officer — Medical Devices

Risk Specialist Issue, Incident and Quality Management

Warranty Engineer

Supplier Dev Engineer

QA Engineer Logistics (Fixed-term, 12 months)

More jobs to discover

Ik wil de nieuwste vacature-alerts ontvangen voor de functie van quality manager in soesterberg

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