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.