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Quality Manager - Medical Devices

TEC PARTNERS LIMITED
Job LocationCambridge
EducationNot Mentioned
Salary50,000 - 60,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent , full-time Work from home

Job Description

This role is for a high-growth, digital health medical device start-up company who are looking for a Quality Manager to join their expanding team. They are currently working on an in-vitro diagnostic product that is set to revolutionise the prevention ofdiseases, with the view to expand into a variety of applications.. They are a digital health company, with a significant link up smartphone applications. The role will involve working closely with senior management to drive company strategy from a regulatoryand quality perspective. They are already ISO13485 accredited but are now looking for an experienced Quality Manager to join and get their product CE Marked and push for FDA approval simultaneously.Quality Manager Requirements:

  • Proficient working to quality management systems (ISO 13485) and any other associated documents
  • Management and development of the companys existing TFs, for CEs, FDA and UKCA
  • Able to maintain and develop current standard operating systems (SOPs)
  • Proven ability organizing and meeting regulatory obligations throughout the full product lifecycle
  • Minimum of 5 years experience working on Quality and Regulatory roles within diagnostic or medical devices
  • Competence with internal and external audit program
  • Confident leading and coordinating regulatory activities supporting assigned projects
  • Outstanding knowledge of the in-vitro diagnostic industry and regulations (IVDD/IVDR)
  • Strong communication, interpretation and presentation skills/abilities
  • Passionate about technology, health care and entrepreneurship
  • Accountable for regulatory compliance for defined projects, brands and/ or portfolio including, but not limited to, new and existing products, packaging and communications Experienced working in cross-functional teams
  • Driven, motivated and organised
  • Comfortable working independently with a high level of accountability
This crucial role affords you the benefit of being part of an up-and-coming company who are set to take the market by storm with their life changing product once FDA and CE marking have been approved. In return, they can offer a competitive salary, flexibleworking hours and the option of part-remote working.If this role sounds of interest, please apply right away with an updated CV.

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