Regulatory Affairs Director
Vor 4 Tagen
About the Role:
EPM Scientific is seeking a highly skilled Head of Regulatory Affairs to join our team. As a key member of our organization, you will play a critical role in ensuring the compliance of our medical devices with regulatory requirements.
Key Responsibilities:
- Develop, revise, and maintain quality management documentation to ensure compliance with medical device regulations.
- Oversee adherence to relevant regulatory requirements, including the Medical Device Regulation (MDR) and ISO 13485, ensuring that products meet the highest standards.
- 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:
- A 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.
- Deep understanding of key industry standards and regulations, particularly ISO 13485 and the Medical Device Regulation (MDR).
- 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.
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