Head of Quality and Regulatory Affairs

vor 3 Wochen

Berlin, Berlin, Deutschland EPM Scientific Vollzeit
Join Our Team as a Head of Quality and Regulatory

EPM Scientific is seeking a highly skilled and experienced Head of Quality and Regulatory to lead our quality management and regulatory affairs efforts. As a key member of our team, you will be responsible for ensuring compliance with medical device regulations and standards, including ISO 13485 and the Medical Device Regulation (MDR).

Key Responsibilities:
  • Develop, revise, and maintain 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.
  • Contribute to the organization, execution, and follow-up of internal and external audits.
  • Create and manage technical documentation related to medical devices.
  • Perform process validation activities (IQ/OQ/PQ) to ensure compliance with applicable regulatory standards.
  • Conduct Failure Mode and Effects Analysis (FMEAs) to identify potential risks and develop strategies to mitigate them.
  • Monitor quality control procedures to ensure consistent compliance with established standards and best practices.
  • Support the development lifecycle of new medical devices, ensuring quality and regulatory standards are integrated into the design process.
  • Manage and evaluate suppliers to ensure that supplier quality meets company and regulatory standards.
Requirements:
  • A degree in engineering, natural sciences, or a related field, with a specialization in medical technology or a similar discipline preferred.
  • 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).
  • Proven experience in preparing for and managing audits and inspections by regulatory bodies or certification organizations.
  • Strong expertise in process validation (IQ/OQ/PQ) and Failure Mode and Effects Analysis (FMEAs).
  • 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.

We offer a dynamic and innovative work environment, competitive compensation, and opportunities for professional growth and development. If you are a motivated and experienced professional looking for a new challenge, please submit your application.

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