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Quality & Regulatory Manager

TEC PARTNERS LIMITED
Job LocationCambridge
EducationNot Mentioned
Salary65,000 - 75,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent , full-time

Job Description

Quality & Regulatory Manager TEC Partners are pleased to be recruiting a Quality & Regulatory Manager for a high growth digital in-vitro diagnostics start-up to join their expanding team following a recent round of successful funding. Aiming to improve global health through a digitalplatform allowing easy and immediate blood testing, health assessment and follow-on care to implement lasting change within the medical device sector. Your responsibility as the Quality & Regulatory Manager will be to help take the product from Clinical toCommercial production on a global scale while working in a in a fast paced, close knit environment giving guidance to senior and junior members of staff.Quality & Regulatory Manager Role:

  • Quality assurance of Medical Devices to ISO 13485 standards, as well as ensuring company procedures and processes align to ISO 13485 and 21 CFR Part 820
  • Responsible for product release to the market
  • Responsible for the IVDR directive
  • Providing support and training to staff in operation of quality assurance and control methods
  • Ensure effective coordination and implementation of regulatory activities in support of product development, registration and life cycle maintenance
  • Manage regulatory agency and submissions ensuring compliance for the development of new products
Quality & Regulatory Manager Requirements
  • Minimum of 5 years experience with an IVD manufacturer
  • Excellent knowledge of the in-vitro diagnostic industry and regulations (IVDD and IVDR)
  • Experience conducting internal audits and hosting external audits
  • Demonstrate a clear understanding of ISO 13485:2016 and the detectives for CE marking
  • Experience with Medical Device Software Development is beneficial
As an integral part of the busiess and my clients product is set to hit the market, you will be rewarded with competitive salary options, private health insurance and life insurance.If this opportunity is of interest, please apply with an up to date CV.

Keyskills :
IVDTechnical FilesISO 13485Quality Management SystemsCE Marking

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