Senior Regulatory Affairs Specialist – 12-Month FTC | Remote | £55,000–£60,000

We're recruiting on behalf of a growing medical device company for a Senior RA Specialist to cover maternity leave, with a strong likelihood of becoming a permanent role.

This is a broad, hands-on position sitting within a collaborative regulatory affairs team. You'll be picking up change control, submissions, competent authority and notified body correspondence, PMS reporting, and mentoring junior team members. The company is in an exciting phase as MDR certification is incoming for one of their brands, which means plenty of meaningful work ahead.

What the role involves:

Regulatory submissions across FDA 510(k), CE Mark, UKCA, Health Canada and international markets. Change control support. Lifecycle maintenance including PMS data collection and PSUR writing. Biocompatibility reviews. Representing RA in cross-functional meetings. Being a go-to resource fo...