Head of Regulatory Affairs and Product Management

vor 1 Tag


Aachen, Nordrhein-Westfalen, Deutschland Vivalyx GmbH Vollzeit

{"h2": "Mission and Vision", "p": "At Vivalyx GmbH, a medical technology startup based in Aachen, we're driven by a mission to revolutionize the field of organ transplantation. Our innovative approach aims to significantly improve the availability and vitality of donor organs. As we navigate the certification process and related studies, we're seeking a dedicated team member to join us as the Head of Regulatory Affairs and Product Management.", "h2": "Key Responsibilities", "ul": [{"li": "Develop and implement strategies to meet regulatory requirements, from strategic planning to preparing technical documentation, in collaboration with our internal team and external partners."}, {"li": "Manage negotiations with partners and suppliers, ensuring that our operations comply with quality management standards such as ISO 13485 and 21 CFR 820."}, {"li": "Craft and implement regulatory strategies, including liaising with regulatory bodies and ensuring compliance with relevant standards and regulations."}], "h2": "Requirements", "ul": [{"li": "Passion for working in medical technology development and a strong sense of ownership, drive, independence, and commitment."}, {"li": "A technical or scientific degree or equivalent training, with several years of experience in the medical device sector, ideally within a startup or SME."}, {"li": "Expertise in regulatory affairs and project management, including proficiency in Microsoft Office and fluency in English, both written and spoken."}, {"li": "Ideally, experience with ISO 13485, ISO 14971, 21 CFR 820, and MDR, as well as knowledge of standards such as IEC 60601 and IEC 62366."}]}



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