Risk Management Manager - 14791 / Medical Devices -South Manchester

Real Time Recruitment Solutions
approx 40,000
11 Oct 2016
22 Oct 2016
Contract Type
Risk Management Manager - 14791 / Medical Devices -South Manchester This is a permanent job. Responsibilities: Lead Risk Management activity for assigned Projects at Product level. Generate and maintain Risk Management Files, Usability Files and when applicable Technical Files, including co-ordinating input from other functions especially Clinical Operations. Take minutes of Risk Management meetings, generate and distribute minutes. Coordinate with the Risk Management team and collate input necessary for Risk Assessment. Maintain assigned product design control documentation e.g. Risk Management assessment, Risk Management File, Usability File, Technical File. Monitor actions related to Risk Management activities. Prepare and process document changes, including generation of new documents Generate and maintain communication/information systems e.g. Unified Communications tool Ensure compliance to Quality Systems requirements for assigned deliverables e.g. risk management files, usability files, design history indexes, technical files Produce regular metrics relating to Risk Management activities, as required Provide input to Project team on process improvements and best practices which result in more effective execution towards reducing time-to-market and effective Risk Management documentation. Work cross functionality and cross site to ensure activities and potential improvement work is aligned and harmonised. Proactively escalate issues and risks to Line Manager. Qualifications: Degree in engineering or science, or equivalent industry background Strong knowledge of application of Risk Management (to ISO 14971) of IVD / medical devices – preferably within an industry that develops and manufactures complex hardware-software high-technology products. Demonstrated expertise in managing projects through a Product Development Process Exceptional interpersonal and leadership skills with excellent communication and presentation skills. Ability to function independently with excellent organization and time management skills Knowledge and use of a variety of risk management tools, usability methodologies to drive product quality and compliance. Demonstrated ability to apply risk management practices in efficient and effective ways while ensuring compliance. Solutions-based approach to compliance. Understanding of relevant regulatory requirements (e.g. IVDD, MDD, FDA) and standards (e.g. ISO 13485, 14971, BS EN 62304, 62366) preferred. Excellent communication (written and oral), analysis and decision-making skills. Good word processor and ability to manipulate large spreadsheets. Proven ability to facilitate activities, lead teams and contribute in a team environment. Ability to travel (domestic and international) Please send your CV ASAP - urgent Urgent role - please apply now Please note that no terminology in this advert is intended to discriminate on the grounds of age, and we confirm that we will gladly accept applications from persons of any age for this role. This job was originally posted as www.totaljobs.com/job/66853835

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