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Quality Manager, Medical Device, ISO 13485

Job LocationLondon
EducationNot Mentioned
Salary45,000 - 60,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

Quality Manager, Medical Device, ISO 13485Were looking for an experienced Quality Manager or Regulatory Manager to join an incredible medical technology company. The successful candidate will need to be in the Oxford office 2 days a week, with the rest of the week working from home.The CompanySpun-out from Oxford University 2 years ago, the Quality Manager will be joining a talented and dedicated team as they continue to develop proof of principle technology into a fully functioning MHRA-approved product prototype. Using ultrasound technology,the company has developed a novel, minimally-invasive surgical procedure that has the potential to transform spinal surgery.The RoleWorking closely with the heads of departments, and reporting directly to the CEO, the Quality Manager will have day-to-day responsibility for the Quality Management System, designing, implementing and maintaining ISO 13485-ready processes and documentation,as well as ensuring that all staff are trained in and adhering too, the QMS.The Quality Manager will also be responsible for the preparation of documentation to support clinical trials, and will lead on the evaluation, selection and implementation of an eQMS.Whats Required

  • Experience in compiling technical documentation for class II and/or class III medical devices
  • Experience of maintaining an ISO 13485 Quality Management System
  • Experienced in interpreting the regulatory requirements for medical devices in the EU and/or USA
  • Experience in providing regulatory support for new product development and/or early stage medical device companies would be highly-advantageous
  • Experience of eQMS solutions such as Codebeamer X, Dot Compliance, Greenlight Guru, etc., would be useful
What NextIf you have any questions or would simply welcome a chat about this excellent Quality Manager / Regulatory Manager position and company, just call me or drop me an email, as Id love to hear from you! If, though, you think this role could be right for youand youd like to learn more, then please apply now.Quality Manager, Regulatory Manager, Medical Device, ISO 13485Corriculo Ltd acts as an employment agency and an employment business.

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