Vigilance Manager

Job Ref: J25228
Sector: Engineering
Sub-sector: Medical Devices
Date Added: 15 February 2018
  • Chester, Cheshire, England, UK
  • £45,000 - £60,000 per Annum
  • Laith Mustafa
  • 0161 868 2231

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Vigilance Manager - Medical Devices - £CompetitiveSRG are currently recruiting for a Vigilance Manager to join a Medical Device company in the North West on a permanent basis at a competitive salary and benefits package, depending on experience.Reporting to the Director, you will be responsible for managing the day to day functions of Medical Device Vigilance in accordance with the organization's policies and applicable regulations, supporting the successful delivery of business strategy, Key Tasks will include:* Log adverse event reports, incidents and complaints received relating to their medical device portfolio in line with standard operating procedures* Follow up adverse event reports, incidents and complaints investigation* Perform decisions on reportability for devices.* Approval of reportable adverse event records.* Liaise with Medical Advisors, local affiliates and third party manufacturers.* Coordination of the preparation, review and submission of Post market Data where required, including PMS Reports and trending* Manage Vigilance training* Review and update Vigilance Standard Operating Procedures* Run vigilance meetings as appropriate* Assist in the management of Vigilance Agreements with distributors and partners for all medical devices.* Collaborate with the wider regulatory team with respect to vigilance aspects of registration dossiers and to prepare relevant documentation for registration * Assist in the management of any contracts which relate to vigilance* Deputise as vigilance correspondent/contact for authorities/notified bodies on behalf of local affiliates as needed * Keep up to date with Vigilance legislation and guidelines and advise management of upcoming changes* Assist Vigilance and Compliance Manager with claim and litigation casesSkills & Experience Required:* Scientific degree (ideally pharmacy, pharmaceutical sciences, chemistry or related) or equivalent* Comprehensive experience of medical device vigilance (ideally 5years+)* Up to date knowledge of relevant legislation in terms of vigilance* First class organisational skills* Able to think strategically and be operational * Credible and confident communicator (written and verbal) at all levels in order to communicate well with internal (regulatory, quality, R&D) and external stakeholders* Highly customer focused* Excellent project management skills* Hands-on approach, with a "can do" attitude* Ability to prioritise, demonstrating good time management skills* Experience of line management* English fluent* Windows conversantFor more information, please call Laith Mustafa on 0161 868 2231 or email

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.