Vigilance Specialist

At Biosense Webster, Inc., we have one goal - to help those with cardiac arrhythmias live the lives they want. Are you someone who would like to make an impact to your community? Would you like to work with a highly dynamic and diverse team ,with credo based values? If yes, our job posting may be of interest to you. The Vigilance Specialist would be responsible to process EMEA complaints and vigilance in accordance with the 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. This role will report directly to the Sr Manager Quality EMEA. We are looking for a highly enthusiastic colleague with an eye for detail, who is eager to learn and open to new challenges. We look forward to hearing from you!. Key Responsibilities: Working with minimal supervision and in accordance with all applicable national laws/regulations and Corporate procedures and guidelines, this position will review complaint documentation and obtain adequate information to ensure proper entry and validation of complaints, as back up for Juarez Complaint team: Key responsbilities:. • Ensures all applicable MDV regulatory reporting decisions, as required. & 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 and have a 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 • Responds back to field representatives and EMEA affiliates offices within 1 business day in response to email or voice mail messages. Composes customer or affiliate complaint investigation responses • Supports Field Action coordinator in Field Action managemen • 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 customer • 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 BS degree in science with 2-3 years experience within a regulated medical device/clinical environment preferred; or equivalent combination of education and experience English proficiency oral and written, must have adequate computer skills to evaluate trending data, complete regulatory reports, and provide written correspondence to internal and external customers including regulatory bodies as appropriate. Ability to communicate with affiliate in additional languages is an asset. Ability to use computers and computer based software & to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals Primary Location Belgium-Brussels-Capital Region-Diegem- Organization Johnson & Johnson Medical NV (7546) Job Function Quality Requisition ID 2206021518W