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Alsinova, the Astek Group subsidiary offering a complete CRO solution, is recruiting a Senior Preclinical Biostatistician for a project in the pharmaceutical sector. Your mission (should you decide to accept it) As a Regulatory Affairs Officer, you will contribute to ensuring that the company's IVD products remain compliant with the evolving IVDR regulations and other applicable standards. Your daily activities will be Support regulatory activities related to CE marking under IVDR Prepare, review, and update technical documentation (TD) for IVD products in accordance with IVDR Annex II & III Ensure compliance of labeling, Instructions for Use (IFU), and claims with IVDR and applicable national regulations Participate in gap assessments, risk management documentation, and post-market surveillance strategies Contribute to interactions with notified bodies or regulatory authorities as needed Collaborate cross-functionally with QA, R&D, Clinical, and Marketing teams You Higher education in Life Sciences, Regulatory Affairs, or related field. 2-5 years of experience in regulatory affairs for medical devices or IVDs. Solid understanding of EU Regulation 2017 / 746 (IVDR) and related guidance. Experience with technical documentation, CE marking, and notified body submissions. Knowledge of ISO 13485, risk management (ISO 14971), and post-market requirements. #J-18808-Ljbffr
