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Head of Quality and Regulatory Expert
vor 2 Monaten
EPM Scientific is seeking a seasoned professional to lead our quality and regulatory efforts as the Head of Quality and Regulatory. This is a fantastic opportunity to join a dynamic team and contribute to the development of cutting-edge medical technology.
Key Responsibilities:
- Develop and maintain quality management documentation to ensure compliance with medical device regulations, including the Medical Device Regulation (MDR) and ISO 13485.
- Oversee adherence to regulatory requirements, ensuring that products meet the highest standards of quality and safety.
- Conduct internal and external audits to ensure that all procedures and processes are thoroughly reviewed and compliant.
- Create and manage technical documentation related to medical devices, ensuring accuracy and regulatory compliance.
- Perform process validation activities (IQ/OQ/PQ) to ensure that all processes meet 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, providing insights and ensuring that quality and regulatory standards are integrated into the design process.
- Manage and evaluate suppliers, including conducting audits to ensure that supplier quality meets company and regulatory standards.
Requirements:
- Bachelor'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).
- Proven experience in preparing for and managing audits and inspections by regulatory bodies or certification organizations.
- Strong expertise in process validation (IQ/OQ/PQ), ensuring that all procedures align with industry standards.
- Ability to conduct detailed Failure Mode and Effects Analysis (FMEAs) to identify risks and recommend improvements.
- Experience in overseeing supplier quality, including conducting thorough supplier audits and evaluations.
- Strong analytical skills and the ability to break down complex systems and processes into actionable tasks.
- 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 English, enabling clear and effective collaboration across teams.
- Proficient in MS Office and familiar with quality management software, enabling effective documentation and process management.
- Demonstrated ability to work independently and approach tasks with a structured and meticulous work style, while maintaining a strong focus on detail and accuracy.
