Seeking trilingual profiles for a rewarding role! > Baxter > Joboolo BE :
Company : Baxter Location : Braine-l'Alleud Wallonia From : Talent BE
Each of us are driven to help improve patients’ lives worldwide.
Join us as we revolutionize kidney care and other vital organ support.*Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.Are you a skilled administrative professional with a passion for Healthcare? Do you speak Dutch, French, and English fluently? Look no further than Baxter!As a global leader in medical technology, we're seeking talented individuals like you to join our team as Regulatory Affairs Specialists.In this exciting role, you'll be responsible Renal and Acute Therapy products:
Ensure timely preparation, submission and appropriate follow-up of variations and renewal applications.
Act as contact person with local authorities.Respond to questions from regulatory authorities in agreement with the Global Regulatory Lead.Ensure high quality labeling translation and artwork managementReview promotional materials for compliance with local regulationsMaintain good relationships with internal (Global Regulatory Leads, Pharmacovigilance, Business partners, Market Planners, …) and external regulatory contacts (local regulatory authorities)Monitor applicable EU and local regulations, perform impact analysis where needed and keep internal partners appropriately informed.Provide regulatory guidance to business, tenders and project teamsQA SupportSupport Corporate Quality Systems implementation including local requirements to CQA and distributionCoordinate Field Actions implementationHandle non conformities, CAPA and change controlsProvide support in case of inspectionsRequirements:
Proficiency in Dutch, French, and English (written and spoken)Strong attention to detail and dedication to accuracyPrevious experience/background as Medical translator, Medical secretary or similarExcellent communication and interpersonal skillsProficiency in Microsoft OfficeWe look forward to hearing from you! Baxter Braine-l'AlleudWallonia
