Lead Regulatory Affairs Specialist (m/f/d)
On-siteBerlin, State of Berlin, Germany
Job Summary
Compile approval-relevant documents including free sales certificates and legalizations for medical devices. Manage documentation evaluations by notified bodies and control technical documentation as part of the conformity assessment procedure. Support design control processes, risk management, clinical evaluations, and usability files. Review and release approval-relevant documents such as risk analyses, design validation plans, and product labeling. Process regulatory evaluations for change orders and handle RA-related inquiries. Interface with customer RA departments, notified bodies, and authorities while supporting audits. Process safety-related complaints in cooperation with Medical Affairs. Initiate and monitor measures to maintain the quality management system while ensuring strict compliance with safety and environmental regulations.
Required Qualifications
- Long-term (5-8 years) of extensive and well-founded functional professional experience
- Completed studies in the natural sciences, engineering, medical or comparable field
- Advanced training 'Manager Regulatory Affairs for Medical Devices'
- Languages: English Level CEFR C1*
- Languages: German Level CEFR B2*
- Quality-oriented, reliable, and dependable
- Self-motivated
- Team player
- Independent and self-reliant
- Excellent communication skills
- Well-structured and systematic way of working
- Willingness to travel to different NOVT locations and business partners - Up to 10% traveling time
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