Regulatory Affairs Manager

A Regulatory Affairs Manager is required to work for a world-class medical device manufacturer in Sheffield. With around 250 heads and a £30M turnover, this is a great opportunity for a Regulatory Affairs professional to add a world-class business to their resume. You will provide a service to ensure compliance with the legal requirements for all medical devices regulations, CE marking, licensed product for manufacture and sale. Regulatory Affairs Manager duties include: - Liaise with the relevant authorities regarding product manufacture and compliance with Medical Devices Directive, Cosmetic Directive, Biocide Directive and licensed products requirements - Maintain all policies in line with Medical Devices Directive - Ensure that sterilised product conforms to the required standards - Validate the sterilisation process and monitor the product produced - Establish and maintain the CE documentation to ensure that the products manufactured meet with the legislation in force - Administer the registration of CE devices and licensed medicines manufactured or sold - Provide advice on packaging and labelling requirements, ensuring compliance with the directives - Ensure compliance of GMP guidelines in manufacturing situations We are interested in speaking to candidates with the following skill set: - Proven experience in a Regulatory Affairs role in medical devices - Degree in either Chemistry or Biology - Professional, enthusiastic personality - Detail driven Are you passionate about driving change in a business where Regulatory Affairs is the key to the business? This is a great opportunity for a Regulatory Affairs Manager to join a business as it enters an exciting period. Elevation Engineering & Manufacturing is a specialist recruitment consultancy dealing with senior engineering, technical and operational positions in Yorkshire and the surrounding regions. If you match the specified criteria and are interested in discussing the position in more detail, we would love to hear from you. Please visit our website for more information on: - Engineering Jobs or Engineering Recruitment - Manufacturing Jobs or Manufacturing Recruitment This job was originally posted as www.totaljobs.com/job/89772661