A Class i Medical Device manufacturer are hiring a Group Regulatory Lead.
It’s a predominantly remote role where you’ll get the autonomy to do things your way.
You will act as the group's regulatory subject matter expert, responsible for ensuring that all new and existing products meet applicable regulatory and safety requirements in all target markets across multiple sites.
You will guide teams on standards, risk management, technical documentation, and product safety, while rationalising and maintaining technical files.
There are five UK sites, all with their own quirks, some are doing things well, others need a bit more guidance. It’s all about having the character to educate, rather than police.
What you need to know:
💻 Mostly remote (you’ll barely leave your home office)
💰 £55–65k depending on experience
🩺 Private medical + pension
👤 This is a stand alone RA role, with scope to hire once you’re settled (1-2 hires)
What skills we need to see:
* 5-10 years’ regulatory experience in medical device design & manufacture, minimum Class I, Class IIA would be advantageous.
* Experience of working in a manufacturing environment in accordance with the requirements of ISO 13485, ISO 9001, ISO 14001 & the EU Medical Device Directive/ Medical Device Regulations.
* Experience taking medical devices into new overseas markets.
* Conversant with EU, APAC and most importantly the US/FDA.
* Biocompatibility ISO 10993 experience would be the icing on the cake.
Although the role is remote, there will be occasional travel to the clients manufacturing facilities. Given their locations, someone based Midlands or above, would be preferable.