Job ad: Regulatory Affairs professional

Regulatory Affairs professional

Exciting new opportunity for a Regulatory Affairs professional to join our small but dedicated Regulatory Affairs team based at our site in Gørløse, Denmark.

In this role you will provide regulatory affairs support, maintain and update medical device regulatory filing including product registrations, and technical files.

The position will be vigilant of implementing updated standards and regulations and their impact on product regulatory status. In addition, you will take part in the Post Market Surveillance activities and will act as a regulatory consultant for other functions to ensure regulatory compliance across all products and processes.

What will you do?

• Ensure availability of up-to-date Design History Files for regulated products to be in compliance with the regulations
• Prepare, submit and manage regulatory filings required for product market approvals as necessary