Regulatory Affairs Manager About Us We are a leading manufacturer of high-quality implants based in Stuttgart, supplying a diverse range of medical devices to global companies and direct customers. Our commitment focuses on quality, reliability, and customer satisfaction to ensure optimal patient care. Key Responsibilities: Research, evaluate, and implement regulatory and normative requirements for medical devices Conduct comprehensive GAP analyses and create technical documentation Develop and update risk analysis reports Manage national and international approval, renewal, and change procedures Coordinate communication with regulatory authorities and distributors Maintain post-market surveillance systems Support broader quality management initiatives Requirements: Engineering degree or equivalent professional qualification Proven experience in regulatory affairs and quality management Comprehensive knowledge of regulatory frameworks: - EU Regulation 2017/745 - ISO 13485 and 14971 - FDA and MDSAP standards (preferred) Strong technical documentation skills Excellent English & German communication abilities Demonstrated teamwork and attention to detail