Senior Regulatory Specialist

The Senior Regulatory Specialist position centres on regulatory submissions across FDA 510(k), CE Mark, UKCA, Health Canada and international markets. It would suit someone who can bring careful technical judgement and practical problem-solving to the role.

Known job details

• Pay: £55,000 - £60,000
• Contract: Contract
• Work model: Remote
• 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.

Likely focus of the role

• 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.

Requirements mentioned

• The company is in an exciting phase as MDR certification is incoming for one of their brands, which means plenty of meaningful work ahead.