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Clinical Diagnostics, IVD, Hospitals

Covering the following locations: Birmingham, Conventry, Derby, Dudley, Leicester, Stoke-on-Trent, Telford, Worcester, Walsall, Wolverhampton

Regulatory Affairs Specialist- IVD

Do you want to work for and make a real impact on a £130m turnover, private equity backed international healthcare business? This organisation leads the way in specialist protein diagnostics, is built on strong scientific foundations with extensive expertise in antibody specificity technology. Our teams give clinicians and laboratory staff the tools to significantly improve diagnosis and management of patients across a range of cancers and immune system disorders.
Due to the company's ongoing and phenomenal growth they are looking for a Regulatory Affairs Manager to join the growing team.
This is a great opportunity for someone who has previous experience working in Quality Assurance/Regulatory Affairs role within the healthcare industry (pharma, medical devices or diagnostics)
The successful candidate will be required to:
· Regulatory review and inputs for controlled documents
· Assist in compilation of global regulatory affairs submissions including STED CE file, FDA
· Assist in all regulatory affairs activities contributing to overall company objectives
· Support internal audits and 3rd party audits
· Support compliance activities for QMS to meet regulatory requirements including MDSAP
· Multi-department and multi-level interactions
Essential Requirements:
· B.Sc. in Life sciences (or equivalent)
· Management or supervisory in Quality Assurance/Regulatory Affairs, in the healthcare industry (pharma, medical devices or diagnostics)
· Management or supervisory in cGMP or regulated environment compliant with ISO13485, 21 CFR part 820 or equivalent.
· Excellent communication skills (both written and Verbal
· Scientific knowledge and experience or working with healthcare products
· Regulatory Affairs and / or Quality assurance background
· To be focussed and have the ability to work as part of a team.
· To be motivated and have the ability to motivate others
· To be friendly and approachable and have a positive attitude
· To be flexible to the needs of the business

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* Salary Guide
£Speak to Liam
Job Ref: 66233

Liam Whelan

Executive Recruiter 01494 818 027

Libby Messitt

Scientific Recruiter 01494 818 018

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