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Zest Scientific recruitment is partnered with a leading manufacturer of Medical Devices in the North West who have a requirement in their regulatory team for a Regulatory Affairs Manager. The Regulatory Affairs Manager job is an outstanding opportunity for a Regulatory professional with experience of working with Medical Devices / IVD regulated products. The Regulatory Affairs Manager will be based out of the Cheshire office which has excellent commuter links to Liverpool, Chester, Manchester and Staffordshire.
The Regulatory Affairs Manager will primarily focus on Cytology and Histology Laboratory Instrumentation with some responsibility supporting regulatory compliance for consumable products. You will assess current systems and procedures to develop an effective regulatory strategy to ensure registration compliance of the Medical Devices. The Regulatory Affairs Manager will maintain contact with the regulatory authorities (MHRA) and develop regulatory approval pathways for new and modified products which will require liaison with R&D and Marketing functions.
It is imperative that candidates applying for this position will need to demonstrate previous experience within a Regulatory Affairs function in the Medical Devices field. The Regulatory Affairs Manager will have knowledge of ISO13485 and FDA QSR Part 820 Quality System Regulation. Experience re registering products is equally desirable. The organisation is restructuring the manufacturing process from Mainland Europe and the Far East to the Cheshire production facility, consequently, candidates who can demonstrate previous experience in a similar structure will be highly sought after.
The salary package ranges from £45,000 - £55,000 (DOE) plus a range of additional benefits. In order to discuss this opportunity in greater detail contact Zest Scientific today on 0114 2381724, alternatively forward an updated CV