Head of Regulatory Affairs and Product Management

Vor 6 Tagen

Aachen, Nordrhein-Westfalen, Deutschland Vivalyx GmbH Vollzeit

Vivalyx GmbH is a medical technology startup that aims to revolutionize the field of organ transplantation. We are seeking a highly skilled and experienced professional to join our team as the Head of Regulatory Affairs and Product Management.

About the Role

The successful candidate will be responsible for leading the registration and market launch of our dedicated product. This will involve crafting and implementing strategies to meet regulatory requirements, from strategic planning to preparing technical documentation. The ideal candidate will have expertise in regulatory affairs and project management, including liaising with regulatory bodies.

Key Responsibilities

  • Develop and implement regulatory strategies to ensure compliance with relevant regulations and standards
  • Prepare and submit technical documentation to regulatory authorities
  • Collaborate with internal teams and external partners to ensure smooth product development and launch
  • Manage negotiations with partners and suppliers to ensure compliance with quality management standards
  • Stay up-to-date with changes in regulatory requirements and industry standards

Requirements

  • Strong background in regulatory affairs and project management
  • Experience in the medical device sector, preferably in a startup or SME
  • Expertise in regulatory affairs, including liaising with regulatory bodies
  • Knowledge of relevant regulations and standards, such as ISO 13485, ISO 14971, 21 CFR 820, and MDR
  • Strong communication and interpersonal skills
  • Fluency in English, both written and spoken

What We Offer

Vivalyx GmbH offers a dynamic and challenging work environment, with opportunities for professional growth and development. We prioritize flexibility and offer mobile working conditions. Our team is highly skilled and motivated, and we are committed to supporting each other's success.

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