Regulatory Affairs Expert

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 strategies for FME products and oversee preparation of Free Sale Certificates, declarations, and site registrations
- Lead regulatory aspects of product and process changes, including Declarations of Conformity, documentation, and marketing material reviews

Your profile:

- Bachelor’s degree in Technical, Engineering, or Scientific fields
- Minimum of 1 year in Regulatory Affairs or Quality Assurance in Medical Devices or Medicinal Products
- Knowledge of development and manufacturing processes (at least 2 years)
- Familiarity with quality management and risk management standards (e.g., ISO 13485, ISO 14971)
- Understanding of medical device regulations (e.g., MDD 93/42/EEC, 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

Kindly be advised that this position is limited to 18-months.