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Becton Dickinson
,
Wokingham, Berkshire
Quality Compliance Lead
Overview
BD is a global medical technology company focused on improving drug therapies, enhancing the quality and speed of diagnosing infectious diseases, and advancing research and discovery of new drugs and vaccines.BD provides an environment which enables our highly talented workforce to be the best at their professions. We are always seeking people who have a passion and commitment to join our Company on its journey to be a leader in ‘advancing the world of health’ BD is recruiting a Quality Compliance Lead to provide quality compliance support to the Worldwide Infusion Specialty Disposables (WWISD) portfolio of products. You will be responsible for overseeing and participating in day-to-day compliance activities relating to product situation analysis, notification and evaluation of incidents, competent authority inquiries and follow up, field actions and Quality Management System process integration and alignment. You will proactively address WWISD compliance needs for products and processes in EMEA and other geographies outside the U.S. (as applicable). As Quality Compliance Lead , you will, Lead the resolution of current WWISD compliance issues as assigned by the Senior Director EMEA Quality Compliance Support integration of new business acquisition processes and procedures into the existing BD model; identify and implement optimization opportunities Manage relationships with competent authorities, ensuring deliverables and timelines are met Assess reported events to determine regulatory reportability; prepare vigilance/regulatory reports as well as communications to Competent Authorities, as required Liaise with and support US colleagues regarding US FDA reporting for products holding US FDA 510(k) clearance Work with business leaders on identified projects and support key business goals and objectives Participate in the preparation and execution of FSCA/FSN for impacted products Escalate high-priority issues as well as identified business risks to the Senior Director EMEA Quality Compliance and other relevant management Support and participate in audits performed by internal and external (e.g. Notified Body) representatives Represent WWISD Quality at scheduled risk management and business meetings The successful candidate will be educated to degree level in a Science related area or equivalent experience and have demonstrated clinical knowledge and experience in medical device and QA and/or RA, preferably in compliance-based roles. You will have an in-depth knowledge of European Medical Device Directive and the new Medical Device Regulation, experience in Adverse Event handling in accordance with applicable MEDDEV and FDA guidance as well as other European/Emerging Market/international geography regulatory requirements for post market activities. You will have demonstrable experience dealing with competent authorities and other regulatory bodies. You will have project management and/or process change (process improvement) experience with the ability to simultaneously work on multiple projects/activities of various disciplines. You will have the ability to critically think, solve problems (i.e. solution seeker) and meet deadlines. You will have a conscientious, detail-orientated approach to work If you’re a team player who is passionate about manufacturing and ‘advancing the world of health’ and we’ve just described your career aspirations, then please APPLY. interested in a career with BD, but this position doesn’t fit your skills and experience? Join our talent community here. emea.jobs.bd.com