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Head of Quality & Regulatory Affairs

£70,000 to £80,000
Job Type
5 Sep 2022
Head of Quality & Regulatory Affairs TEC Partners are pleased to be recruiting a Head of Quality & Regulatory Affairs for a high growth, next generation med tech company. My client have developed several ground-breaking technologies which address global needs for high throughput laboratory and remote testing. Your responsibility as the Head of Quality & Regulatory Affairs will be to help take the products from Clinical to Commercial 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. Head of Quality & Regulatory Affairs 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 Head of Quality & Regulatory Affairs 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 directives for CE marking Experience with Medical Device Software Development is beneficial Experience of performing internal audits As an integral part of the business aiding my client's products to hit the within the next year, you will be rewarded with competitive salary options and further development opportunities. If this opportunity is of interest, please apply with an up to date CV
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  • Job Reference: 704623127-2
  • Date Posted: 5 September 2022
  • Recruiter: Tec Partners
    Tec Partners
  • Location: London
  • Salary: £70,000 to £80,000
  • Sector: Healthcare & Medical
  • Job Type: Permanent