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Regulatory Affairs Director

vor 2 Monaten


Berlin, Berlin, Deutschland EPM Scientific Vollzeit

About the Role:

EPM Scientific is seeking a highly skilled Head of Regulatory Affairs to join our team. As a key member of our organization, you will play a critical role in ensuring the compliance of our medical devices with regulatory requirements.

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, ensuring that products meet the highest standards.
  • 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, providing insights and ensuring that quality and regulatory standards are integrated into the design process.

Requirements:

  • A 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 in a similar regulated environment.
  • Deep understanding of key industry standards and regulations, particularly ISO 13485 and the Medical Device Regulation (MDR).
  • Ability to work independently with a high level of precision and attention to detail, while also effectively managing multiple tasks and projects.
  • Exceptional communication skills in both German and English, enabling clear and effective collaboration across teams.
  • Proficient in MS Office and familiar with quality management software, enabling effective documentation and process management.