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 seasoned quality and regulatory expert to oversee the development, revision, and maintenance of quality management documentation to ensure compliance with medical device regulations.

The ideal candidate will have a deep understanding of key industry standards and regulations, particularly ISO 13485 and the Medical Device Regulation (MDR).

Key Responsibilities:
  • Develop and implement quality management systems to ensure compliance with regulatory requirements.
  • Oversee adherence to all 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, providing insights and ensuring that quality and regulatory standards are integrated 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 in a similar regulated environment.
  • 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 seeking a talented individual to join our team.

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