We have an exciting opportunity for a Regulatory Affairs Specialist 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, 510k 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:
- 3+ years in Regulatory Affairs (Medical Devices)
- Experience with QMS
- Auditing experience
- CE marking experience
- Experience of working with International teams
- Strong Communication Skills
- Strong Project Management skills in Regulatory Space
- Native German and Fluent English
- IT Proficiency
