Regulatory Affairs Specialist

vor 1 Woche

Northeim, Niedersachsen, Deutschland GULP – experts united Vollzeit

We are seeking a highly skilled Regulatory Affairs Manager to join our team at GULP – experts united. As a key member of our team, you will be responsible for managing the Regulatory Affairs department, including the preparation, review, processing, and submission of documents to relevant authorities.

Your Key Responsibilities:

  • Develop and implement regulatory guidelines
  • Review and comply with regulatory procedures and workflows
  • Develop optimal strategies
  • Interface with global regulatory authorities and external consultants
  • Train, mentor, and supervise employees, consultants, and contractors in the area of regulation
  • Support interdisciplinary teams as an advisor on regulatory issues

Your Profile:

  • You have successfully completed your studies with a scientific focus
  • Experience in the field of medical devices or in the biotechnology industry
  • Proven experience in actively leading a team
  • Very good knowledge in the interpretation of regulations, guidelines, policy statements
  • You are experienced in the preparation of marketing authorization applications
  • Prioritization of work packages, both for yourself and for your team
  • You enjoy working effectively and cooperatively in cross-functional international teams
  • Fluent written and spoken German and English and a willingness to travel (max. 10%) round off your profile

About Us:

GULP – experts united is a dynamic company that values sustainability, openness, and joy. We offer a comprehensive social package, attractive fixed salary, and opportunities for personnel development.

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