Regulatory Affairs Specialist.

Job ID: 10735

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Regulatory Affairs
Ihre Aufgaben
  • Work closely with product development, clinical, quality, and marketing teams to gain required information for new product submissions and provide regulatory input to project teams
  • Establish regulatory registration strategies/plans and estimate registration timelines
  • Compilation, preparation, review and submission of technical files to authorities
  • Assure regulatory compliance and maintain the technical documentation throughout the product lifecycle
  • Perform other related duties and responsibilities, on occasion, as assigned
Ihr Anforderungsprofil
  • Degree in engineering or life sciences with at least basic knowledge of the human circulatory system
  • At least 3 years professional experience in medical device industry and regulatory affairs
  • Knowledge of European regulatory affairs framework, general standards and guidelines for medical devices
  • Ability for strong attention to detail in a complex work environment with multiple and competing priorities
  • Good interpersonal and communication skills
  • Highly motivated and open-minded team player
  • Very good German and English, spoken and written
  • Sound knowledge of Microsoft Office applications