Regulatory Affairs Specialist

4 weken geleden

Amsterdam, Noord-Holland, Nederland Go Office Voltijd
Job Summary

The Regulatory Affairs Associate role at Go Office involves a unique blend of analytical and practical skills. As a key member of our team, you will be responsible for coordinating changes that impact technical documentation, ensuring compliance with medical device regulations.

This is a broad role that requires a strong command of English and a good command of Dutch. You will work closely with our team to develop evaluations for efficacy, safety, and risks, as well as clinical evaluation and post-market follow-up reports.

Key responsibilities include:

  • Conducting desk research and assisting in writing clinical and biocompatibility assessments for technical product documents.
  • Database research on specific ingredients to gather supporting evidence.
  • Developing evaluations for efficacy, safety, and risks, as well as clinical evaluation and post-market follow-up reports (CERs and PMCF reports) in accordance with medical device regulations.
  • Keeping the technical documentation up-to-date with applicable regulations and standards.

Additionally, you will provide support for country registrations (via distributors) for countries outside the EU where this organization operates.

We are looking for a highly motivated and organized individual with a strong background in writing scientific texts in English. If you have a passion for the medical industry and a willingness to work in a smaller organization, we encourage you to apply.

Requirements
  • Completed HBO or university degree (e.g., in pharmacy, biochemistry, biology).
  • Excellent command of the English language and a good command of the Dutch language (minimum level B2).
  • Experience in writing scientific texts in English.
  • Affinity for the medical industry.
  • Willingness to work in a smaller organization.
  • Residing in or near Amsterdam.
  • Authorized to work in the Netherlands.
What We Offer

We understand that good compensation means more than just a competitive salary. Enjoyment in your work and a good work-life balance are equally important. The more enjoyment you have, the greater your contribution to the products of this organization.

Additionally, you will receive:

  • A broad salary range based on your level and experience, Between €3,000 - €6,000 gross per month.
  • Good secondary employment benefits.
  • 8% holiday allowance.
  • 6% pension provision.
  • Bonus scheme.
  • Use of Apple laptop.
  • Travel allowance based on public transport.
  • Fun outings with the team.

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