Head of Quality and Regulatory
vor 3 Wochen
My client prides themselves on fostering a culture of innovation and are a fantastic start up developer focusing on state-of-the-art Medical Technology. They are looking for a new Head of Quality and Regulatory to get the ground up and running on this new venture.
Responsibilities:
- 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.
- Contribute to the organization, execution, and follow-up of internal and external audits, ensuring that all procedures and processes are thoroughly reviewed.
- Create and manage technical documentation related to medical devices, ensuring accuracy and regulatory compliance.
- Perform process validation activities (IQ/OQ/PQ), ensuring that all processes meet applicable regulatory standards.
- Conduct Failure Mode and Effects Analysis (FMEAs) to proactively identify potential risks and develop strategies to mitigate them.
- 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.
- Manage and evaluate suppliers, including conducting audits to ensure that supplier quality meets company and regulatory standards.
Ideal Candidate Profile:
- 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 in 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 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.
- Demonstrated ability to work independently and approach tasks with a structured and meticulous work style, while maintaining a strong focus on detail and accuracy.
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