Senior Regulatory Affairs Specialist

Indo Professionals Ltd ,
Oxford, Oxfordshire
More Details
Salary: Up to £60,000 per annum pension, healthcare

Overview

Senior Regulatory Affairs Specialist Oxfordshire Perm £60k plus benefits Our client is a small, growing developer of an advanced active medical device, they are currently looking to hire the services of a Senior RA Specialist to join their team in Oxfordshire. Salary: Circa £60,000 per annum plus benefits Location: Oxfordshire – ideal for a RA Specialist residing in or near the areas of Oxford, Abingdon, Didcot, Witney, Banbury, Swindon, Reading, Aylesbury, M40 / M4 corridors. Or for someone looking to relocate Position: Senior Regulatory Affairs Specialist / Medical Device RA Specialist Ideal applicant: Our client is looking for a proven, senior level Regulatory Affairs Specialist with a proven track record within medical device product development for UK and ideally US markets. The ideal applicant will also have: - Circa 10 years’ experience within a regulatory affairs position – or can demonstrate a rapid rise within regulatory affairs to a senior level - Experience in Class IIa/IIb or class III devices – essential - Ideally experience with active / programmable / software driven medical devices - Strong knowledge of the new MDR requirements - Strong attention to detail with a technical / analytical background - FDA / 510K submissions experience - Excellent communication skills and strong presentation skills - Experience of clinical evaluation would be an advantage Job role: Reporting to the RA/QA and Compliance Director, this position will work closely with the senior management and engineers to generate Technical Files and to support for maintenance for the Quality Management System (QMS). In addition, this role will have a focus on the generation and implementation of regulatory changes for the MDR transition. Core responsibilities for this RA Specialist role include: - Management of MDR transition - Generation of all technical files and relevant changes to QMS - MDR Gap Assessment (BSI) - Ensuring successful re-certification - Provision of support to QA, maintaining regulatory compliance - Support changes to the existing 510K - Post market Surveillance & vigilance activities - Support new software development activities - Support Internal audits Job reference: J0023419 Indo Professionals is a specialist medical device staffing business focused on placing high calibre professionals into regulatory affairs, quality assurance and clinical research positions UK wide. If you are looking for a new career challenge or would like a career consultation with an industry expert, please contact the team today. Keywords: 13485, reg, ra, reg manager, ra manager, qa, qa manager, qms, quality, 510k, fda, ce, ce mark, Oxfordshire, Berkshire, Hampshire, London, m4, m3, Abingdon, oxford, didcot, submission, submissions, qms, 60601, 62304, fda, 510, 510k This job was originally posted as www.totaljobs.com/job/89785997

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