Regulatory Affairs Manager

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