Vigilance Specialist

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This position is based in the European HQ in Belgium. The Vigilance Specialist (formerly titled « Complaint Analyst ») is responsible to process EMEA complaints and vigilance in accordance with established company procedures and applicable regulations and standards. The position is responsible to maintain a high level of customer satisfaction and responsiveness to internal and external customers, affiliates as well as EMEA regulatory bodies with regard to product complaints or inquiries. The Vigilance Specialist reports directly to the Sr Manager Quality EMEA. DUTIES & RESPONSIBILITIES* Under minimal supervision and in accordance with all applicable national laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position: • Reviews complaint documentation and obtains adequate information to ensure proper entry and validation of complaints, as back up for Juarez Complaint team. • Ensures all applicable MDV regulatory reporting decisions, as required. • Ensures all MDV regulatory reports are completed and reported according to regulatory requirements. • Possesses understanding of European medical devices regulations and keeps abreast of changes in the regulatory environment • Possesses thorough understanding of complaint database. • Develops, prepares and analyzes trend reports for complaints, as required. • Requires fundamental understanding of basic principles, theories, concepts and techniques related to customer complaints. • Facilitates follow-ups with International Technical Services, US complaints team, EMEA Clinical team, responsible manufacturers and Regulatory as needed. • Composes customer or affiliate complaint investigation responses. • Supports Field Action coordinator in Field Action management • Supports product rework at EDC as needed • Supports Stop Shipment process as needed • Inspects returned products at EDC • Supports Clinical Department for Adverse Event reconciliation • Ensures the regulatory reporting of serious adverse events from pre-market studies are completed and reported according to regulatory requirements. • Alerts supervisor as appropriate of critical communication from customers. Maintains knowledge of Biosense Webster products and their use. • Documents all information according to Biosense Webster policy and EMEA regulatory standards • Educates field sales force and affiliates in utilization of complaints department for reporting of field complaints • Participates on project teams to improve department processes. • Responsible for ensuring personal and company compliance with all local and company regulations, policies and procedures • Responsible for communicating business related issues or opportunities to next management level • Responsible for ensuring personal and Company compliance with all National and Company regulations, policies, and procedures • Performs all duties and responsibilities in accordance with any professional requirements as well as those found in applicable policies and procedures and the Credo • Performs other duties assigned as needed Qualifications EXPERIENCE AND EDUCATION* • BS degree in science with 2-3 years experience within a regulated medical device/clinical environment preferred; or equivalent combination of education and experience Primary Location Belgium-Brussels-Capital Region-Diegem- Organization Johnson & Johnson Medical NV (7546) Job Function Quality Requisition ID 2105972317W