Head of High quality & Regulatory Affairs

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TEC Companions are happy to be recruiting a Head of High quality & Regulatory Affairs for a high-growth digital in-vitro diagnostics start-up to affix their increasing staff following a latest spherical of profitable funding. Aiming to enhance international health by way of a digital platform permitting straightforward and speedy blood testing, health evaluation and follow-on care to implement lasting change inside the medical gadget sector. Your duty because the Head of High quality & Regulatory Affairs will probably be to assist take the product from Scientific to Industrial manufacturing on a world scale whereas working in a fast-paced, close-knit atmosphere giving steerage to senior and junior members of workers. Head of High quality & Regulatory Affairs Function: High quality assurance of Medical Gadgets to ISO 13485 requirements, in addition to guaranteeing firm procedures and processes align to ISO 13485 and 21 CFR Half 820 Accountable for product launch to the market Accountable for the IVDR directive Offering help and coaching to workers in operation of quality assurance and management strategies Guarantee efficient coordination and implementation of regulatory actions in help of product improvement, registration and life cycle upkeep Handle regulatory company and submissions guaranteeing compliance for the event of latest merchandise Head of High quality & Regulatory Affairs Necessities Minimal of 5 years’ expertise with an IVD producer Wonderful information of the in-vitro diagnostic business and rules (IVDD and IVDR) Expertise conducting inner audits and internet hosting exterior audits Reveal a transparent understanding of ISO 13485:2016 and the detectives for CE marking Expertise with Medical Gadget Software program Growth is helpful As an integral a part of the enterprise aiding my consumer’s product to hit the market this years, you can be rewarded with aggressive wage choices, personal health insurance and life insurance. If this chance is of curiosity, please apply with an updated CV.
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