jobno-005892-Germany

Regulatory Affairs Manager (m/f/d)

직무 번호

005892

직종

Research & Development

근무 시간

  • Regular Fulltime

채용 지역

Jena

우리가 제공하는 것:

설명 목록

  • Drive of the development of regulatory strategies and act as interface for the field of regulatory requirements for internal and external partners
  • Collaborate in multi- site projects for new registrations, registration of product changes or regulation-induced changes
  • Advice development departments/teams regarding the quality, analytical methods, pre-clinical and clinical development to ensure acceptance of the data worldwide
  • Prepare and submit applications for new markets authorizations/registrations and respond to questions in a timely and accurate manner
  • Together with Business Management and Logistics, ensure the market availability of our products

교육 목록

  • Masters or PhD in natural scientific or medical device engineering background (e.g.: pharmacist, biologist, chemist,…)
  • 3-6 year of experience in international regulatory affairs field for medical devices
  • Medical device regulatory experience with EU MDD/MDR and US FDA
  • Knowledge of DIN EN ISO 13485
  • Ability to act in a multicultural and cross-functional environment
  • Excellent skills in English and German (verbal & written)
  • Excellent communication and networking skills

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