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RA Manager In Vitro Diagnostics

Job LocationManchester
EducationNot Mentioned
Salary£50,000 - £65,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

We are currently supporting a multi-national and market leading business within the field of in-vitro diagnostics (IVD) to recruit a new Regulatory Affairs Manager to join their technical team.The business:With a big focus on product development in recent years and expanding into new markets, this is a great opportunity to play a key role as part of a wider team that are at the forefront of their industry for years to come. This is a business that are actively playing a role in combating Covid 19 and the global Coronavirus epidemic.They have invested heavily into attracting and retaining highly skilled people across different functions within their company, so youll be working with a team of very capable professionals.The role and key responsibilities for the Regulatory Affairs Manager will involve:The core of this role will be key to supporting the overall regulatory affairs strategy within the company to ensure they are working towards their wider company goals. You will oversee international product registrations, lead the RA team and be responsible for technical files for the upcoming IVDR.Key responsibilities will include:

  • Leading a small RA team
  • Managing and leading with IVDR planning transition within the company.
  • Supporting post-market surveillance activity within the company.
  • Responsible for leading, creating and maintaining technical files as well as preparing regulatory dossiers and maintenance of import/product licences.
  • Communicating key regulatory information across the business and being a contact to stakeholders at all levels within the company on key regulatory/technical issues.
  • Managing relationships with regulatory agencies
  • The ideal candidate for the Regulatory Affairs Manager will have the following background:
  • Experience working as Regulatory Affairs Manager within the field of In-Vitro Diagnostics (IVD) and/or Medical Devices
  • Will have led small RA teams
  • Good knowledge of IVD Regulations and Directives.
  • Experience working with ISO 13485 standards.
  • Degree or equivalent experience within life sciences field - ideally in Molecular Biology or Genetics.
  • The role will be suitable if you live within - Manchester, Bolton, Warrington, Stockport, Liverpool, Northwich, Rochdale, Cheshire, Leeds, ChesterFor more information, please contact Martin Ofosu at Radar Recruitment.

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