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Head of Regulatory incl. Project Management

vor 3 Monaten

Cologne, Deutschland Vivalyx GmbH Vollzeit

At Vivalyx, a medical technology startup based in Aachen, we're on a mission to save the lives of those suffering from organ failure. Our innovative approach aims to significantly improve the vitality and availability of donor organs. As we gear up for certification and related studies, we're seeking dedicated team members (m/f/d) to join us starting from December 1, 2024, or later, for 32-40 hours per week.

We provide the opportunity to work on groundbreaking technology that has a meaningful impact. You'll be part of a dynamic, highly skilled, and motivated team. We prioritize flexibility, offering mobile working conditions and a flat hierarchical structure. In addition, we support professional development and career growth, along with an attractive employee participation program.

Tasks

As the Head of Regulatory Affairs and Product Management, you will lead the registration and market launch of a dedicated product. You will be the go-to person for regulatory matters of that product, both within our team and to external partners. Your responsibilities will include crafting and implementing strategies to meet regulatory requirements, from strategic planning to preparing technical documentation, in collaboration with our internal team and external partners. Given our small team size, you will also be hands-on in writing regulatory documents. Additionally, you will manage negotiations with partners and suppliers, ensuring that our operations comply with quality management standards such as ISO 13485 and 21 CFR 820.

Requirements
  • Passion for working in medical technology development
  • Strong sense of ownership, drive, independence, and commitment
  • A technical or scientific degree or equivalent training
  • Several years of experience in the medical device sector, ideally within a startup or SME
  • Expertise in regulatory affairs and project management, including liaising with regulatory bodies
  • Ideally, experience with ISO 13485, ISO 14971, 21 CFR 820, and MDR
  • Preferably, knowledge of standards such as IEC 60601 and IEC 62366
  • Proficiency in Microsoft Office and fluent in English, both written and spoken

We look forward to hearing from you.