We have an exciting opportunity for a Senior Regulatory Affairs Manager to join the team. The client is an established leader in the Medical Device market and operates globally.
Responsibilities:
- Main point of contact for notified bodies
- Experience managing global regulatory submissions including FDA submissions
- Regulatory consultant in the launch of new products
- Maintenance of European Regulatory Compliance
- Supporting Registration Support and Regulation Assessment.
- Revision of technical documentation, creation of various documents and creation of risk analyses
- Research change procedures
- Post-market Surveillance
Requirements:
- 5+ years in Regulatory Affairs (Medical Devices and IVD)
- Experience with QMS
- Experience of working with International teams
- Strong Communication Skills
- Strong managements skills, working with different departments
- Excellent command of English and ideally German proficiency
- IT Proficiency
