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