Regulatory Affairs Manager (f/m/d) - Freelance | Medical Devices
Start: immediately - up to 80% remote
As a Freelance Regulatory Affairs Manager (f/m/d) you will be responsible for bringing medical devices to the EU market and supporting global regulatory approvals for a renowned medical devices manufacturer in Baden-Württemberg.
Your tasks:
- Implementation of the requirements of worldwide approvals of our leading medical products
- Coordination and execution of regulatory activities for the development programs
- Development and implementation of regulatory strategies
- Management, coordination, and compliance of technical documentation for international approval of medical devices, considering country-specific requirements
- Preparation of and compliance with approval plans
- Regulatory review and evaluation of product changes
- Work closely with cross-functional teams to bring products to market quickly and efficiently
- Contribute to the development of the product development and change process
- Participation in CAPA's
- Timely application and implementation of regulatory requirements
Your profile:
- Successfully completed studies in natural sciences or comparable qualification
- Team spirit, open communication, integrity, flexibility, commitment, and willingness to learn
- 2+ years of professional experience in the approval of medical products
Additional knowledge:
- Knowledge of MDR and other regulatory requirements
- Basic Knowledge in compliance engineering
- Experience with studies, risk assessment
- Experience in medical device development
- Advanced English skills
