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Medical Device Regulatory Affairs Associate

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Medical Device Regulatory Affairs Associate – Loughborough Opportunity: Are you currently working in medical device regulatory affairs? Have you compiled Technical Files for CE Markings? Have you prepared dossiers for FDA submissions? Want to work for an innovative manufacturing company with great career development? If yes then please read on. Your role as a Regulatory Affairs Associate based in Loughborough will involve working with Class 1, Class 2 and Class 3 medical devices preparing regulatory submissions for global product registrations / approvals for new products / line extensions. You will be working on new medical device products to ensure the appropriate licensing, marketing and legal compliance of the company’s medical device products and activities. Other duties include: • Producing medical device Design Dossiers, Technical Files and Device Master Files for CE marking approval. • Preparing dossiers for FDA submissions. • Preparation of regulatory submissions for global product registrations / approvals for new products / line extensions. • Updating and reviewing of IFUs, packaging, patient information leaflets, labelling and marketing literature for medical device products. • Maintaining and developing on quality systems such as GMP, ISO 9001 and ISO 13485. • Quality assurance. This is a full time permanent job opportunity paying an excellent salary between £30,000 – £40,000 per annum dependent on skills and experience and excellent benefits. Skills: To apply for the role of Medical Device Regulatory Affairs Associate you will have: • Several years medical device regulatory affairs experience. • Experience in compiling Technical Files for CE Marking approval. • Experience in preparing dossiers for FDA submissions. • Experience of working with quality systems e.g. ISO 13485, GMP and ISO 9001. How to Apply: To apply for this one off opportunity, please send a word copy of your CV to me now by clicking on the Apply button or call me for a confidential chat. Please ensure you have read and agree to our Privacy Policy which can be found on our website. If this sounds like the role for you or a colleague then please don’t hesitate to contact us. If we manage to successfully fill a permanent placement from your recommendation then we will send you a cheque of £300. We also have many incentive schemes for referring contractors/temp staff so please contact us with the referral and we can provide you with more information. For a list of our current vacancies, please visit www.qualitystart.co.uk If you do not hear from Quality Start within 2 weeks your CV has not been short listed for this role. Quality Start are acting as a specialist recruitment consultancy for this role.

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