QA/RA Manager Medical devices

Templarfox Consultancy Ltd ,
Shipley, West Yorkshire
Salary: From £45,000 to £60,000 per annum

Overview

QA/RA Manager Medical Devices – Yorkshire I am recruiting on a permanent basis in the Yorkshire region for a QA/RA manager to work within a medical devices business. The client is agile, successful privately owned business. You will be responsible for o Responsible for compliance and diligence of product technical product files o Provide expert advice in Medical Device Regulations (MDR) – Class I and II. o When required liaise with regulated bodies – MHRA, FDA o Compile and control product technical files for all new MDR product registrations o Review compliance and update existing product technical files. o Investigation & resolution of complaints, Process quality improvements and traceability o Experience ideally of post market and clinical evaluation o Provide control and auditing of suppliers – quality & ethical, gap analysis, o Ideally an understanding of retail distribution of medical devices products The ideal candidate: o Will have a degree or equivalent qualification in a science based subject. o It is essential that you have a minimum of 5 years experience on product file management within medical devices or related products ideally with Class 1 or Class 2 medical devices. o Previous industrial experience of MDR, regulatory submission, quality supplier auditing, Quality systems(QMS) o Proative and engaging with the continued growth of the brand and business o Positive communication engaging with all levels and proactive Key Words: QA, Quality Risk Management, Quality Systems, Supplier Management, Audits, regulatory affairs, ISO13485, BRC, HACCP, Compliance, technical files, MDR, If you believe you hold the relevant background experience and looking for a new role as QA/RA Manager within this independent successful and growing business then this is the role for you. About us: Templarfox if a privately owned recruitment business leading in executive search, management selection, Salary benchmarking and Business development services. The recruiter has stated that all applicants for this job should be able to prove that they are legally entitled to work in the UK and on this occasion TemplarFox Consultancy is acting as an employment agency.