Regulatory Affairs Specialist
1 maand geleden
The Regulatory Affairs Associate will play a key role in ensuring the company's products comply with regulatory requirements. This includes coordinating changes to technical documentation, conducting research, and developing evaluations for efficacy, safety, and risks.
This is a broad role that involves dealing with all aspects of technical documentation. The position requires a strong analytical mindset, excellent communication skills, and the ability to work independently.
Responsibilities- Coordinate changes to technical documentation, including conducting desk research and assisting in writing clinical and biocompatibility assessments.
- Develop evaluations for efficacy, safety, and risks, as well as clinical evaluation and post-market follow-up reports.
- Keep technical documentation up-to-date with applicable regulations and standards.
- Provide support for country registrations for countries outside the EU.
- Completed HBO or university degree in a relevant field.
- Excellent command of the English language and a good command of the Dutch language.
- 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.
We offer a competitive salary, good secondary employment benefits, and a fun and dynamic work environment. You will have the opportunity to further develop yourself and manage your time well both inside and outside the office.
Additionally, you will receive:
- A broad salary range based on your level and experience.
- 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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