Regulatory Affairs Specialist
4 weken geleden
The Regulatory Affairs Associate role at Go Office involves coordinating changes that impact technical documentation, including conducting desk research, writing clinical and biocompatibility assessments, and developing evaluations for efficacy, safety, and risks. This position requires a strong analytical approach and practical skills to manage various projects.
Key Responsibilities
- Coordinate changes that impact technical documentation, including assessing whether the change impacts the documentation.
- Conduct desk research and assist in writing clinical and biocompatibility assessments for technical product documents.
- Develop evaluations for efficacy, safety, and risks, as well as clinical evaluation and post-market follow-up reports.
- Provide support for country registrations via distributors for countries outside the EU where Go Office operates.
Requirements
- Completed HBO or university degree in a relevant field, such as pharmacy, biochemistry, or 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
- A competitive salary range based on 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.
How to Apply
Send an email with your CV and motivation to danique@go-office.nl or apply via the application form below.
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