Regulatory Affairs and Product Management Expert

vor 2 Wochen


Köln, Nordrhein-Westfalen, Deutschland Vivalyx GmbH Vollzeit
Overview

Vivalyx GmbH, a pioneering medical technology startup in Aachen, is dedicated to revolutionizing organ transplantation by developing innovative solutions. As we prepare for certification and related studies, we seek a skilled professional to join our dynamic team.

Compensation

We offer an attractive salary of €60,000 - €80,000 per year, commensurate with experience, to support the selected candidate's career growth.

Job Description

As the Head of Regulatory Affairs and Product Management, you will be responsible for leading the registration and market launch of a cutting-edge product. Your key tasks will include:

  • Crafting and implementing strategies to meet regulatory requirements
  • Preparing technical documentation in collaboration with internal teams and external partners
  • Managing negotiations with suppliers to ensure quality management standards compliance
Key Requirements

To succeed in this role, you will need:

  • A strong passion for medical technology development
  • Excellent ownership, drive, independence, and commitment
  • A technical or scientific degree or equivalent training
  • Multiple years of experience in the medical device sector, preferably in a startup or SME environment
  • Detailed knowledge of regulatory affairs and project management principles
  • Familiarity with ISO 13485, ISO 14971, 21 CFR 820, and MDR regulations
  • Proficiency in Microsoft Office and fluency in English, both written and spoken
Benefits

We offer a flexible work environment, mobile working conditions, and a flat hierarchical structure. Our company prioritizes employee development and career growth, providing opportunities for professional growth and an attractive employee participation program.



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