Compliance & Vigilance Manager

Job Ref: J23560
Sector: Engineering
Sub-sector: Medical Devices
Date Added: 13 September 2017
  • London, England, UK
  • £55,000 - £65,000 per Annum
  • Laith Mustafa
  • 0161 868 2231

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Complaints & Vigilance Manager - Medical Device - London - £CompetitiveSRG are currently recruiting for a Complaints & Vigilance Manager to join a Global Medical Device company in London on a permanent basis at a competitive remuneration package, depending on experience.Reporting to the QA/RA Director, you will be responsible for managing a team of engineers and specialists to provide regulatory and compliance support for the company in regards to the investigation and reporting of complaints for the company.Responsibility for the management of the field safety corrective action process. Key tasks  Manage a team of engineering and scientific professionals and technicians in the complaints and vigilance Department.  Allocate and manage appropriate resources, budgets and timescales to ensure timely delivery of key objectives. Actively participate on design teams to support manufacturing. Provide feedback to key stakeholders on device performance for the improvement of the manufacturing processes for existing and new products.  Work closely with key stakeholders to resolve in-house and supplier quality product issues identified through complaints or NC/CAPA process.  Provide technical expertise and support on device performance to the business  Ensure that compliant and accurate SOPs/WIs are in place. Review/approve nonconforming material and system documentation. Participate in continuous (breakthrough) improvement activity and process projects in support of the business* Achievement of strategic goals and annual operating budgets Ensure the complaint reporting team members work to current procedures. Ensure complaints are closed in line with corporate requirment and in accordance with metrics. Manage the complaint investigation activities. Effectively manage FSCA activies for the site in line with company requirements. Responsible for effective communication and system upgrades for the complaints team. Create and ensure maintenance of a complaint database in accordance with FDA requirements. Responsible for both supporting PMS and providing data as required by Clinical Affairs. Manage day to day team activities and requirements. Manage through HR the personal requirements of the team. Organise development plans and support training activities for the team. Provide guidance, advice and technical assistance where necessary. Review and manage the complaint database to supply complaint data to support complaint review. Liaise when necessary, with the competent authorities within the required timeframe. Maintain good and effective intercompany contact with relevant departments. Maintain and update current procedural requirements with the Quality Management Systems, ensuring training records have been captured through HR. Manage the HHE and FSCA activities for the site when and where necessary Qualifications, skills and desirable experience  Bachelor's Degree in a scientific or technical subject and experience working within a quality function in an FDA Regulated Industry, preferably complaint management in medical device manufacturing.  Working knowledge of regulatory requirements: ISO 13485, Quality System Regulation and Medical Device Directive. Demonstrated project and people management skills. Demonstrated verbal, written and interpersonal skills.  Must be able to work in a team environment and interact effectively with management from other functions Analytical and methodical approach to problem solving with effective communication skills at all organizational levels. Ability to lead cross functional teams and manage staff to achieve goals.For 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.