Regulatory Affairs Manager, Medical Devices
LS-1788
Open
Location
Salary
Contract
Permanent
Work model
Hybrid
Seniority
Senior
Closing date
The role
A medical device manufacturer near Manchester is hiring a Regulatory Affairs Manager to own the regulatory strategy for a portfolio of Class IIa and IIb devices sold across the EU, UK and increasingly into the US.
The immediate work is the remaining MDR transition and the UKCA route, including technical file remediation and the notified body relationship. Beyond that, the role owns regulatory input into new product development and the post-market surveillance system.
This is the senior regulatory position on site, reporting to the Quality and Regulatory Director, with one regulatory associate reporting in. Three days on site, two from home.
What you will need
Five or more years in medical device regulatory affairs
Direct, hands-on experience of EU MDR technical documentation and remediation
Managed a notified body relationship through audit or review
Understanding of ISO 13485 and ISO 14971 in practice, not only in principle
Experience of post-market surveillance and vigilance reporting
Familiarity with the UKCA route and, ideally, US FDA 510(k) submissions
Degree in a life science, engineering or related discipline
What is on offer
Salary of £62,000 to £72,000 depending on experience
Two days a week from home
Annual bonus of up to 12%
Private medical cover
Company pension at 7% employer contribution
27 days holiday plus bank holidays
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