Regulatory Affairs Specialist

vor 4 Wochen


Köln, Nordrhein-Westfalen, Deutschland Vivalyx GmbH Vollzeit

We are seeking a highly skilled Regulatory Affairs Specialist to lead the registration and market launch of a dedicated product at Vivalyx GmbH, a medical technology startup based in Aachen. As the go-to person for regulatory matters, you will craft and implement strategies to meet regulatory requirements, from strategic planning to preparing technical documentation, in collaboration with our internal team and external partners.

Key Responsibilities
  • Develop and implement regulatory strategies to ensure compliance with quality management standards such as ISO 13485 and 21 CFR 820
  • Manage negotiations with partners and suppliers to ensure regulatory compliance
  • Prepare technical documentation and regulatory submissions
  • Collaborate with internal teams and external partners to achieve regulatory goals

Requirements

  • Strong understanding of regulatory affairs and project management principles
  • Experience in the medical device sector, ideally within a startup or SME
  • Expertise in regulatory affairs and project management, including liaising with regulatory bodies
  • Proficiency in Microsoft Office and fluent in English, both written and spoken

We are looking for a highly motivated and experienced professional to join our team at Vivalyx GmbH.



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