Clinical Specialist

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Location: Near Wales/flexible Contract type: Full time, Perm Pay rate: (Approx. 60-70K)Clinical Specialist Manages and leads clinical activities on a project basis. This will include clinical representation on New Product Development Core Teams, development of clinical evaluation plans (clinical strategy) and clinical evaluation reports and responsibility for any clinical investigations in line with pre and post market product launch requirements. Clinical input and expertise will also be provided for change control activities, risk management activities (e.g. Product Risk Reviews), complaint evaluations, Health Hazard Evaluation (HHE) preparation, participating in project teams, reviewing Advertising and Promotional Materials from a Medical/Clinical perspective and providing ad hoc clinical advice to support other functions.Main ResponsibilitiesSymbolise clinical affairs on core/project teams for product development and change controlEvaluate and provide input into design history file remediation activities including design verification/validation, hazard analyses, product risk reviews and to prepare and/or update Clinical Evaluation reportsMaintain and amend Clinical Evaluation Reports in accordance with MEDDEV 2.7.1 and GHTF Guidance and internal SOP's.Deliver clinical input into Health Hazard analysesBe responsible for medical review support for MRL approvalCoordinates and /or participates in the timely execution of a clinical investigation from a clinical study plan to final clinical study report within the established timeline and budget.Leads ad-hoc strategic projects.Skills:Understanding of the clinical product development process trialUnderstanding of clinical trial process (may be required to support clinical trial activities)Ability to establish strong working relationships with clinical Investigators and key opinion leaders.Can demonstrate leadership and thorough business ethics If this sounds like something you want to do then contact me! m.zaatriATrealstaffing.com 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