The Lead Regulatory Affairs Specialist ensures that medical devices and the steps involved in developing, testing, and marketing them meet all applicable regulatory requirements
Job Summary
The Lead Regulatory Affairs Specialist ensures that medical devices and the steps involved in developing, testing, and marketing them meet all applicable regulatory requirements.
This role involves managing or being responsible for the compilation of approval-relevant documents and supporting conformity assessment procedures worldwide.
The position also includes control and sole responsibility for reviewing/releasing approval-relevant documents as part of the design control process.
Matching Summary
The Lead Regulatory Affairs Specialist ensures that medical devices and the steps involved in developing, testing, and marketing them meet all applicable regulatory requirements.
Skills & Requirements
Must-have
Regulatory submissions and approvals
Design control processes
Risk management process
Clinical evaluation
Usability file
Reviewing/releasing approval-relevant documents
Nice-to-have
Teamwork, collaboration and empowerment
Quality-oriented, reliable, and dependable
Independent and self-reliant
Well-structured and systematic way of working
Key Requirements
5-8 years functional professional experience
Studies in natural sciences, engineering, medical or comparable field
Advanced training Manager Regulatory Affairs for Medical Devices