Head of Quality and Regulatory Affairs Specialist

vor 3 Wochen

Berlin, Berlin, Deutschland EPM Scientific Vollzeit
Job Title: Head of Quality and Regulatory Affairs

EPM Scientific is seeking a highly skilled and experienced professional to lead our quality and regulatory affairs team.

About the Role

We are looking for a talented individual to oversee the development, revision, and maintenance of quality management documentation to ensure compliance with medical device regulations.

  • Assist in the development, revision, and upkeep of quality management documentation to ensure compliance with medical device regulations.
  • Oversee adherence to all 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

To be successful in this role, you will need:

  • 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.
What We Offer

EPM Scientific offers a dynamic and innovative work environment, with opportunities for professional growth and development.

We are committed to fostering a culture of innovation and excellence, and we are looking for talented individuals who share our values.

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