|Publication date:||January 22 2021|
For a fast-growing organisation that focuses on the development, production, and commercialisation of class III medical devices, we are currently looking for a Regulatory Affairs Specialist. As a Regulatory Affairs specialist play a key part in making sure all products and the company are compliant.
In this role, you maintain compliance with regulatory authorities. To enable this you gather and assemble information that is needed for submissions in accordance with global regulations and guidelines. After submission, you plan and reply to regulatory agencies for questions and other correspondence. With this, you contribute to all risk and safety assessments. Other tasks are being part of solutions for a variety of complex issues that are product or production-related.
We are looking for someone with the following skillset:
The organisation can offer you the following: