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Job Details
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Regulatory Affairs & Quality Manager

Business Type: Medical Devices Company
Job Type: Regulatory Affairs
Job Level: Experienced (non manager)
Position: Full Time
Salary: £45k -£50k + bens
Location: Somerset
Reference: 891098
Job Details:
Regulatory Affairs & Quality Manager – Medical Devices – Sheffield with remote working - £45k -£50k + bens

I’m currently recruiting for a Regulatory Affairs & Quality Manager to join a small, independent medical devices client based in Sheffield, South Yorkshire. You will predominantly be responsible for all regulatory matters relating to their existing products however, there will be some quality management responsibilities too.

The Company

This company is a highly successful, international medical devices client based in Sheffield, South Yorkshire. They have a real down to earth, friendly feel about them and are now looking to recruit a Regulatory Affairs & Quality Manager
·  Highly successful medical devices company
·  Product ranges span from Class I Sterile to Class IIa Sterile
·  International company with products in multiple regions
·  Down to earth, super friendly and supportive company
·  Part time options available for this role (if required)

The Role

The Regulatory Affairs & Quality Manager will be responsible for;
·  Responsible for all regulatory and technical aspects for Class 1, Class 1 sterile and Class IIa products. 
·  Maintaining Product Technical Files (approx. 8 technical files) as well as the Quality Manual
·  Monitor a Class 7 cleanroom ensuring it adheres to ISO 13485:2016 and MDD 93/42/EEC
·  Preparation of regulatory submissions
·  Oversee the QMS


The Regulatory Affairs & Quality Manager will ideally have experience in;
·   Medical Device Regulatory Affairs
·   MDD/MDR knowledge
·   Knowledge of ISO 13485
·   Sterilisation experience is highly desired.

What should you do next?

This Regulatory Affairs & Quality Manager role is one not to be missed; it encompasses the opportunity to work in a small medical devices company that offers excellent flexible working in a hugely supportive environment.  To discuss this Regulatory Affairs & Quality Manager role further or to find out about other Regulatory Affairs jobs I am currently working on, please get in touch or hit apply to submit your current CV.

Unless otherwise stated, if applying for a job within the UK or European Union, you must ensure that you are already authorised to work there.

Carrot Pharma Recruitment Ltd acts as an Employment Business and an Employment Agency on behalf of our client in recruitment for this role.

Posted: 15/06/2021 | NPJ Ref: 272585
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