Head of Regulatory Affairs and Product Management

vor 2 Wochen


Köln, Nordrhein-Westfalen, Deutschland Vivalyx GmbH Vollzeit
About Vivalyx GmbH

Vivalyx GmbH is a medical technology startup based in Aachen, Germany, dedicated to developing innovative solutions for organ transplantation. Our mission is to improve the availability and vitality of donor organs, making a meaningful impact on people's lives.

Job Description

We are seeking a highly skilled and motivated individual to join our team as the Head of Regulatory Affairs and Product Management. As a key member of our team, you will be responsible for leading the registration and market launch of our dedicated product, ensuring compliance with regulatory requirements and quality management standards.

Key Responsibilities
  • Develop and implement regulatory strategies to meet requirements, from strategic planning to technical documentation.
  • Manage negotiations with partners and suppliers, ensuring compliance with quality management standards.
  • Collaborate with internal teams and external partners to ensure seamless operations.
  • Prepare and write regulatory documents, including technical documentation.
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.
  • Ideal experience with ISO 13485, ISO 14971, 21 CFR 820, and MDR.
  • Proficiency in Microsoft Office and fluent in English, both written and spoken.
What We Offer

We provide a dynamic and motivated work environment, flexible working conditions, and opportunities for professional development and career growth. Join our team and contribute to making a meaningful impact in the medical technology industry.



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