Quality Assurance Manager - Clinical Affairs

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A new exciting role has arisen with a Medical Device manufacturer in Manchester. The successful candidate will take on responsibility for assuring the quality and compliance of external verification and validation studies. This includes audits of clinical studies as well as quality oversight of internal related verification/validation activities.You will require both the experience and the vision to create a robust system in conjunction with our existing Clinical Affairs and Quality Affairs departments. Whilst the initial phase of the role will require operational execution of activities personally, there is ample opportunity for the right person to develop the role/function in the coming years. You will be playing a vital role in a company with patient and customers at the heart of everything we do, and dedicated to making improvements in life possible.Key Responsibilities:Demonstrable, working knowledge of global IVD Regulations (minimum EU and USA). In addition significant experience of clinical regulations, standards, guidelines and best practice e.g. CFR 812, BIMO, ISO standards, ICH guidelinesQualified AuditorExperience in performing as a Subject Matter Expert in regulatory inspections and other formal audits e.g. NB auditExcellent knowledge of the in vitro diagnostic industry including product development processes (ISO13485)Ability to work independently while exercising good judgement and decision making within defined practices and policies.Ability to demonstrate and convey high performance, high standards cultureIf you feel you have the skills to suit this role, please apply and I will be in touch. To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales