Regulatory Affairs Expert (m/w/d) (Befristet)

at  Fresenius Medical Care

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
  The position is limited until 31 January 2026.

Regulatory Documentation:

• Develop, maintain, and control global regulatory product documentation (e.g., Global Technical Documentation, Registration Files)
• Oversee content creation and approval of Instructions for Use (IFU), labels, and other regulatory documents
• Provide guidance on compliance standards and associated testing requirements
• Support design and development projects to ensure regulatory compliance
• Align change notifications with Notified Bodies and Authorities

Product Registration:

• Ensure regulatory product availability in global markets in line with commercial strategy
• Coordinate global regulatory activities and strategies for IC products
• Manage product registrations, renewals, and global submissions
• Prepare Free Sale Certificates and declarations for regulatory submissions
• Register medical devices, trading goods, and production sites

Change Management:

• Evaluate, prepare, and implement product and process changes.
• Act as the regulatory change project lead
• Support the creation and review of Declarations of Conformity and related documentation
• Review marketing materials and product-related information