Regulatory Affairs Expert

Regulatory Affairs Expert (Medical Devices)

Your responsibilities:

• Manage global regulatory product documentation, including technical files, registration dossiers, IFUs, and labeling
• Ensure compliance with regulatory standards and testing requirements throughout product design and development
• Coordinate regulatory approvals and change notifications with Notified Bodies and Authorities
• Ensure global regulatory product availability aligned with commercial strategy by managing registrations, renewals, and submissions
• Coordinate regulatory product strategies
• Lead regulatory aspects of product and process changes, including regulatory documentation.

Your profile:

• Master’s degree in Technical, Engineering, or Scientific fields
• Minimum of  8-10 years in Regulatory Affairs or Quality Assurance in Medical Devices or Medicinal Products
• Knowledge of development and manufacturing processes
• Familiarity with quality management and risk management standards (e.g., ISO 13485, ISO 14971, IEC 60601 series)
• Understanding of medical device regulations (e.g., FDA CFR, NMPA, MDR 2017/745)
• Strong communication and interpersonal skills
• Fluent in English, both written and spoken

Our offer for you:

There is a lot you can discover at Fresenius Medical Care, because we have a lot to offer. No matter in which field you are an expert (m/f/d) and how much experience you bring with you - for your professional future with meaning:

• The option to work on a hybrid basis
• Whether in front of or behind the scenes - you are helping to make ever better medicine available to more and more people around the world
• Individual opportunities for self-determined career planning and professional development
• A corporate culture in which there is enough room for innovative thinking - to find the best solution together, not the quickest one
• A large number of committed people with a wide range of skills, talents and experience
• The benefits of a successful global corporation with the collegial culture of a medium-sized company