RA / Regulatory Affairs Specialist

Regulatory Affairs Specialist 

We are looking for a RA Specialist to join our team based in Stuttgart.

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

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

We are a leading manufacturer of ophthalmic implants, 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.