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Regulatory Affairs Associate Medical Devices

Job LocationNottingham
EducationNot Mentioned
SalarySalary negotiable
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent , full-time

Job Description

This role will support the UK & Ireland market with product registrations across Class I, IIa and IIb devicesClient DetailsThis is a fantastic opportunity to join a Medical Care business that puts patients at the heart of everything they do.Description

  • Perform registration of medical devices with MHRA
  • To maintain Technical Documentation Files for devices in accordance with the requirements of the UKMDD for UKCA marking activities
  • Handle regulatory dossiers to support product license applications and product license maintenance
  • Support post market surveillance, preparing reports for the product range according to procedures
  • Developing and maintaining a sound knowledge of European and UK regulatory legislation and guidelines to provide advice and expertise internally for matters related to our products
  • To support companies regulatory planning, developing strategies for the product range in accordance with the UK requirements
  • To support risk management activities and the life-cycle of marketed products
  • Updating and reviewing of IFUs, packaging and labelling
  • Will have ample opportunities to work on a variety of regulatory activities across a range of products including medicines
ProfileExperience and knowledge on the regulatory framework & ISO 13485Job OfferExcellent benefits package availableSalary up to 45K depending on experience

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