Regulatory Affairs Associate

The role of Regulatory Affairs Associate includes both analytical elements and a practical approach to various projects.

Technical Documentation
You will coordinate changes that impact the technical documentation. This includes:

• 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. Coordinating changes that may affect the technical documentation (including assessing whether the change impacts the technical documentation).

Market Access
Providing support for country registrations (via distributors) for countries outside the EU where this organization operates.

In short, this is a broad role where you will deal with all aspects of technical documentation. The position involves a lot of reading, drafting texts, as well as a significant administrative component.

The organization was founded 17 years ago and focuses on the development and sale of consumer health products. With a small and enthusiastic team of 10 people, they have launched three self-developed and patented leading brands in the market. They do everything in-house and take pride in it! This means you will have daily visibility into the work you perform.

The company specializes in product development, registration, setting up the supply chain, and sales & marketing through an international distribution network in over 25 countries. The company is located in the center of Amsterdam.

• 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.

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. Therefore, you will have plenty of opportunities to further develop yourself and manage your time well both inside and outside the office. The employer invests in the training and education of all employees.

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.
• A professional, passionate, and dynamic organization with driven colleagues in a beautiful location in the heart of Amsterdam.

Sollicitatieprocedure

Send an email with your CV (and motivation) to danique@go-office.nl or apply via the application form below!

Check HIER for other vacancies fom Go:Office Recruitment.

For more information about this vacancy, please contact Danique van Houte at  +31 6 1980 3165.