This is a newly created position and will report directly in to the Regulatory Affairs Director. The dynamic Diagnostics company are based in Manchester. The perfect candidate will be an established Regulatory Manager that has previously been hands on with a small to medium team previously with a proven history of success in Regulatory Affairs from within the Medical Device or IVD industry.
RA Manager, £50-60k, Manchester, IVDs, Medical Device
• Lead a team of Regulatory & Quality Specialists
• The creation, management and maintenance of Technical Files for Class I, IIa and IIb Medical Devices
• Management of ISO 13485 & ISO 9001 Quality Management System
• Efficacy data & Stability data
• Design history and design development
• Conducting external and Internal audits across client sites
• Assistance for other RA Executives - Technical file data for dossiers
• At least 5 years Medical Device experience
• Solid experience within Regulatory affairs
• Line Management Experience
• Experience in Biocides Directive
• Experience of the MDD 93/42/EEC with experience of Technical file building and submissions under this Directive (Essential)
• Understanding of cosmetic / Personal Care regulatory affairs is desirable
• BSc (or equivalent) in Science
Please contact Nathan Berkley on 0203 019 6020 or email email@example.com if you would like to know more about this opportunity or similar within Medical Devices. This will be 100% confidential.
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