Regulatory Affairs Manager (m/f/d)
Salary : Negotiable
Location : Stuttgart - Hybrid
We have an exciting opportunity for a Regulatory Affairs Manager to join the team. The client is an established leader in the medical device market and operates globally
Join us now and apply as a Regulatory Affairs Manager (m/f/d):
Responsibilities:
- Research, evaluation and implementation of legal and normative requirements for medical devices
- Implementation of GAP analyses, revision of technical documentation, creation of various documents and creation of risk analyses
- Research into admission requirements and implementation of national and international admission, extension and change procedures
- Communication with the notified body as well as with authorities, suppliers and distributors as part of the approval process
- Maintenance of the post-market surveillance system
- Support for other quality management issues
Qualifications
- Successfully completed engineering degree or comparable qualification
- Professional experience in the field of regulatory affairs
- Knowledge of legal and regulatory requirements such as MDR, ISO 13485 or 14971,FDA or MDSAP
- Knowledge of the international requirements for quality management systems
- Experience in creating technical documentation
- Strong communication skills and good knowledge of spoken and written English
- Commitment, teamwork and a careful way of working
