Regulatory Affairs manager – Medical Devices

A new role in Regulatory Affairs has become available at an exciting medical devices organisation who have products undergoing clinical trials. The role focuses on FDA and UK/EU submissions.

As an experienced Regulatory Affairs professional, you’ll manage and prepare regulatory submissions (e.g., variations, renewals, new market applications) and ensure compliance with U.S. (FDA) and European (EMA) regulations. Key responsibilities include strategic planning, cross-functional coordination with manufacturing, quality assurance, regulatory writing and document review, and liaising with health authorities.

The company has exciting medical device products currently undergoing clinical trials. Head office is based in Oxfordshire.

Key Responsibilities

Submission Strategy

Developing strategic plans for regulatory submissions, including variations, renewals, and new market applications.