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Director of Quality and Regulatory Compliance

vor 2 Monaten


Berlin, Berlin, Deutschland EPM Scientific Vollzeit
Quality and Regulatory Affairs Expert

EPM Scientific is seeking a highly skilled Quality and Regulatory Affairs expert to join our team. As a key member of our organization, you will play a critical role in ensuring the highest standards of quality and regulatory compliance in our medical technology products.

Key Responsibilities:
  • Develop, revise, and maintain quality management documentation to ensure compliance with medical device regulations.
  • Oversee adherence to relevant regulatory requirements, including the Medical Device Regulation (MDR) and ISO 13485.
  • Create and manage technical documentation related to medical devices, ensuring accuracy and regulatory compliance.
  • Monitor quality control procedures, ensuring consistent compliance with established standards and best practices.
  • Support the development lifecycle of new medical devices, integrating quality and regulatory standards into the design process.
Requirements:
  • Master's degree in engineering, natural sciences, or a related field, with a specialization in medical technology or a similar discipline.
  • Extensive experience in quality management and regulatory affairs within the medical device industry or a similar regulated environment.
  • Deep understanding of key industry standards and regulations, particularly ISO 13485 and the Medical Device Regulation (MDR).
  • Exceptional communication skills in English, enabling clear and effective collaboration across teams.
  • Proficient in MS Office and familiar with quality management software, enabling effective documentation and process management.