Helix Biotech is a contract research organisation working on assay development for clinical partners across the Benelux. We are hiring a Regulatory Affairs Specialist to join the Regulatory team.
You will prepare and maintain regulatory submissions and advise product teams on what the rules require. Clear writing and a careful reading of guidance documents are at the centre of the job.
This is a hybrid role based in Amsterdam or Utrecht, with two or three days a week in the office. It is a full-time, permanent position. The pay range for this role is €57,000–€75,000 per year.
This is a fictional posting on the Jobo sandbox. Applications are never sent to a real employer.
What you'll do
- Review labelling and promotional material for compliance.
- Track regulatory changes and assess their impact.
- Respond to questions from notified bodies and authorities.
- Maintain technical documentation.
Qualifications
Must have
- Bachelor's in Life Sciences, Pharmacy, Nursing or a related field
- EU MDR
- Regulatory submissions
- Technical documentation
- Clear writing
Nice to have
- RAPS Regulatory Affairs Certification
- FDA 510(k)
- Negotiation
Benefits
- 8% holiday allowance
- 27 vacation days
- Travel allowance or NS business card
- Laptop and home-office budget
- Conference attendance budget