Head of Vigilance- Medical Devices

We have a new position at Sinclair for a Head of Vigilance. This role is to supervise and support the Vigilance Team for complaint handling, medical device reporting and supporting the manufacturers to investigate complaints for Injectables and Active Device products in accordance with global regulatory requirements and internal policies and procedures. You will directly interface with the Injectables and Active Device manufacturer’s quality teams to deliver results to defined KPI’s and strategic initiatives. You will help develop and lead initiatives to continuously improve quality and efficiency within the Complaint Management Team and as part of the enterprise-wide Quality organisation. Location: Hybrid working 3 days in the office 2 at home, Lakeside, Chester Business Park, Cheshire, CH4 9QT About Sinclair Founded in 1971, Sinclair is a global medical aesthetics organisation, that delivers an extensive product range. With an in-house commercial infrastructure, including manufacturing and a network of distributors in leading global markets, our products are sold in 55 countries worldwide. This is a great time to join Sinclair as we continue to increase our product range and expand into new markets and territories. Our Vision Providing aesthetic excellence globally. Our Mission Driving the advancement of product quality and customer satisfaction, investing in innovation and people. Our Values Act with Integrity Be results driven Embrace your winning spirit Stay ahead of the game One team, one goal Description • Minimum 5 years’ experience in Quality Assurance or Complaint • Management within a Medical Device or Aesthetics organisation • Working knowledge of the Medical Device Regulation • Working knowledge of 21CFR Part 803, 820 • Knowledge of other regulatory Key Responsibilities • Responsible for mentoring, coaching, and developing team members • Lead strategic and department level initiatives focused on improving quality and efficiency within the corporate complaint handling function • Define performance goals and targets, conduct performance reviews, hold individual career development conversations, and regular 1:1s with team members to manage toward achieving team goals • Serve as subject matter expert to answer complaint related questions and bring complex complaint files to completion • Ensure work instructions and procedures are in compliance with all applicable FDA regulations, specifically 21 CFR Parts 820 and 803 and Regulation (EU) 2017/745 • Maintain regulatory, process and product knowledge to provide internal and external audit support • Prioritize and lead/participate in the assessment and solution development for identified issues of moderate to high scope and complexity including CAPAs, non conformances, and quality assurance action plans • Monitors the company’s medical devices surveillance program including the intake, evaluation, processing, and follow-up on adverse reports, participation in the resolution of any legal liability and in complying with government regulations • Maintains the company’s Periodic Safety Update Reports (PSUR) and Post Market Surveillance Plans and Reports program • Ensures complete and accurate maintenance and reporting of Medical Device Reports (MDRs) Medical Device Vigilance System, adverse reaction data as required by global regulatory agencies • Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements Benefits: • 25 days annual leave (plus bank holidays) • Bonus based on performance Free parking • Opportunities for development and progression • Company pension scheme • Private medical insurance • Healthcare Cash plan • Health Screening • Employee Assistance Programme • Store discounts • Tech and Cycle Scheme • Discounted dining card • Cycle to work scheme • Green car scheme • Holiday buy and sell • Life Assurance scheme We have a real focus on developing our people, and by fostering an entrepreneurial culture, we encourage flexibility, accountability and autonomy. The company is full of opportunity for those who wish to grasp it. Our people thrive on engagement, development and a varied workload. You will often be included in projects that require you to collaborate cross-functionally. If this sounds like you and you meet the requirements, please apply, we would love to hear from you. Please note if we receive a high volume of applications, we may close the role before the closing date noted. By making this application you give consent for personal information to be used in automated decision making processes relating to key job requirements which are stated in this ad. If you have any questions, please email gwalker@sinclair.com Sinclair does not accept speculative or unsolicited CVs from Recruitment Agencies. Any unsolicited CVs received will be treated as property of Sinclair and Terms & Conditions associated with the use of such CVs will be considered null and void.