The Quality Management / Regulatory Affairs Specialist is responsible for supporting the quality assurance and regulatory affairs processes within the organization. This role involves the evaluation of products and processes to ensure they meet established high quality standards and legal requirements. Assists in the documentation and quality improvement initiatives. Creation and Evaluation: Collaborate in the establishment, implementation, maintenance and improvement of a quality management system in accordance with national and international standards and regulations. Identify defects or issues and work with the development team to ensure resolution. Documentation and Reporting: Assist in the development and maintenance of quality assurance documentation, including standards and procedures. Support the development department with the creation and maintenance of development files. Process Improvement: Participate in quality improvement initiatives, error analysis and suggest enhancements. Collaborate with team members to identify root causes of quality issues and propose corrective actions. Assist in the implementation of best practices for quality assurance. Compliance and Standards: Ensure that all products and processes comply with relevant industry standards and regulations. Support internal and external audits and inspections related to quality assurance processes. Stay updated on industry trends and standards related to quality assurance. Collaboration: Work closely with cross-functional teams, including development, production, and operations, to ensure quality standards are met. Participate in team meetings and contribute to discussions on quality issues and improvements. Training and Support: Provide support and guidance to other staff and new team members. Participate in training sessions to enhance knowledge of quality assurance practices and tools. Regulatory Affairs: Involvement in the planning and implementation of approval procedures in Germany and abroad as part of an international team to successfully bring products to market. Actively cooperate in the preparation and submission of necessary documents and applications for approval. Conduct independent research, prepare and interpret regulatory requirements (incl. relevant laws, regulations and directives). Communication with regulatory authorities, notified bodies and business partners in regulatory matters.