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.