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.

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.

There is a lot you can discover at Fresenius Medical Care, because we have a lot to offer.
The option to work on a hybrid basis
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

Regulatory Affairs Expert

Key skills