Machelen, Flemish Region, Belgium
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries. Responsibilities: 1/ Effectiveness of the quality management system - Performing CAPA review activities to support effective and timely investigations and corrective actions - Coordinate focused management review meetings, informing management on the performance of the quality system Effective and timely implementation of quality plans in accordance with Abbott Vascular's quality goals Coordination of field actions in the EMEA region - Inspection readiness and audit preparation for the EMEA region Participate in cross-regional and cross-divisional projects, e.g. ComQA and OneAbbott initiatives 2/ Define the EMEA regulatory compliance strategy in close collaboaration with the EMEA commercial team: • Establish a strong and successful relationship with commercial management • Monitor emerging issues and advising on business impact and associated procedural changes • Monitor changes to the regulations within EMEA and advise on business impact in collaboration with the Regulatory Team and ensure any associated procedural changes are implemented • Support the commercial team to develop business projects in accordance with the applicable local regulations as well as Abbott Policies and procedures 3 I Management of the EMEA Quality and Regulatory Compliance Team (Affiliates): Manage, organize and motivate the Affiliate Quality and Regulatory Compliance managers
- Leading the Regulatory Affairs , Quality Affairs and Clinical Affairs Department ( 10 persons) - Providing regulatory compliance advice and guidance to commercial leadership - Managing the Quality Management System according to ISO 13485: 2016 (acts as the Management Representative) - Performing Supplier audits
Assisting the Whole Blood and Automated Collections Business Units in fulfilling regulatory compliance by applying a thorough understanding of regulatory standards requirements to areas of expertise such as the EMEA regulatory framework for Blood component collections and processing. In particular: - Supporting the validation process of Whole Blood Processes in France, Germany, Serbia, Algeria. - Supporting the validation process of Automated Blood collections in Croatia and Morroco - Aligning CaridianBCT regulatory documents with the new European Legislation regarding DEHP.
- Reviewed and summarized all existing clinical study results on Trima Accel® Automated Blood Collection Systems and its competitors to define our device’s claims, build our scientific strategy and plan future marketing/comparative clinical trials to be conducted in 2010-2015 - Developped scientific tools and presentations to provide the Automated Collections Sales Team with a better understanding of the clinical and physiological aspects of blood apheresis, regarding both blood product quality and donors’ safety - Symposium presentation at the Société Française de Transfusion Sanguine (SFTS) Congress 2009 to promote Trima Accel® Automated Blood Collections System