Corin, an orthopaedic medical device business, is currently looking for a Complaints Vigilance Manager to ensure our complaints management procedures are optimized; ensure vigilance team responds to and resolves complaints within a timely fashion whilst conforming to the correct standards and procedures. The Complaints Vigilance Manager is responsible for managing the Vigilance Team.
You will work within the Regulatory and Clinical team based in our global head office in Love Lane, Cirencester, Gloucestershire, which is the home to nearly 400 employees. Corin provides a progressive and dynamic work environment where you can take control of your career, be accountable and drive positive change.
Corin is going through an exciting period of growth with its new investment partner Permira driving global technological / robotic advancements in the implant of hip and knee surgery which in turn delivers better patient and surgeon outcomes.
The responsibilities of the Complaints Vigilance Manager are to:
- Execute complaint vigilance in conformance to current standards and procedures, using applicable system application tools (e.g., QPulse) in accordance with ISO13485/MDR/ 21CFR820 and other regulations as required.
- Lead and mentor the Complaints Vigilance team of 2-5; responsible for team goal setting and performance assessments, as well as day-to-day people management
- Make initial triage assessment of complaints and assess initial risk and severity; Evaluate that information received is sufficiently detailed and request and obtain additional details where incomplete.
- Work with all product/manufacturing/research & development/quality teams to ensure timely, accurate and complete investigations of product complaints and timely closures
- Review reports of customer complaints, assess them for MDR / MDV reportability to FDA / Competent Authorities
- Ensure initial and follow up reports are submitted to Regulatory Agencies within required timelines.
- Ensure complaints are classified correctly and that all supporting data are adequately documented and attached to the complaint file
- Update current procedures/processes or create new procedures/processes
- Generate and track metrics on process timeliness and effectiveness
- Participate in continuous improvement and process re-engineering projects in support of continuous improvement initiatives.
- Generate data for Competent Authorities (FDA, TUV/BSI and other regulatory bodies).
- Post-Marketing Surveillance activities; Supply Product Quality Metrics for Brand Review meetings or PMS reviews.
- Complete, review and approve Complaint Vigilance Reports (i.e. quarterly trending, monthly, complaint records) in a timely manner
- Perform procedural reviews and updates relating to core activities to ensure ongoing compliance and improvement to the QMS, as required.
- Promote alignment between local and regional processes to drive harmonization
- Disseminate training to other Corin UK employees on Vigilance
- Provide an environment that encourages and promotes employee involvement, continuous improvement, and compliance and fosters innovation.
- Responsible for managing the Vigilance team which includes performance assessment, personnel development, establishing annual objectives, and providing day-to-day guidance for the individuals reporting into the Complaint Vigilance Manager.
The ideal Complaints Vigilance Manager will have / be;
- BS degree in Engineering and/or science discipline; MS degree in Engineering and/or science discipline preferred.
- A seasoned Quality leader with a extensive experience in the medical device industry, preferably in Complaints Vigilance/Post-Market Surveillance area.
- Experience with people management
- Demonstrated applied knowledge of regulatory requirements (MDR and MDV)
- Results orientated, multi-tasker, and quick learner; understands and respond to urgency
- Excellent verbal, written and interpersonal skills.
- Applied knowledge of Microsoft Office software including Excel, Word and Power Point.
You will also receive a competitive salary and annual bonus as well as;
- 25 days holiday plus bank holidays.
- Excellent pension – up to 9.7% provided by Corin when you contribute 5%
- Life assurance (6x basic salary).
- Private medical insurance with BUPA for you and your family.
- Subsidised canteen and gym membership.
- Free car parking - close to Swindon, A419, Cheltenham, Gloucester and Stroud.
- Friendly and collaborative working environment