Our Government client is currently recruiting for a Regulatory Affairs and Quality Compliance Manager, on a contract basis paying £400 P/D inside IR35 remote.
Role: Regulatory Affairs and Quality Compliance Manager
Contract Length: 31.03.2022
Location: Leeds/London or remote.
IR35: In scope
Pay Rate to Candidate: £350-400
Essential criteria is that they must have gone through an audit process with medical devices. The medical device can be a simple tool, but they must have some audit experience in this area.
• accountable for regulatory compliance for software medical device for the nhs.uk website.
• internal audit has already been done - it identified some areas to work on with regards to medical devices compliance.
• There is a list, from the audit, need to make a plan and see it through.
• Need to train internal team on requirements going forward.
• Part of small team - Team player.
• Need some clinical knowledge.
• Will deal with fairly senior people – middle to senior management
• Take the lead
• Won’t be in isolation. Risk management team, legal and commercial teams there to support.
• Experience of medical devices needed, even if only simple tools like BMI calculator for eg.
• Be able to demonstrate experience going through this process with medical devices.
Eg 111 service, BMI calculator – the simpler end.
• Experience with auditing tools, putting action plan in place.