Lead Regulatory Affairs Specialist Medical Devices (m/f/d)
Novanta
Berlin, Germany
Medical device regulatory requirements
Regulatory submissions and approvals
Design control processes
The Lead Regulatory Affairs Specialist ensures that medical devices meet all applicable regulatory requirements and that regulatory submissions and approvals are timely performed
Job Summary
The Lead Regulatory Affairs Specialist ensures that medical devices meet all applicable regulatory requirements and that regulatory submissions and approvals are timely performed.
The role involves managing or being responsible for the compilation of approval-relevant documents, control/acceptance of technical documentation, and reviewing/releasing approval-relevant documents as part of the design control process.
Novanta fosters a culture that embraces teamwork, collaboration, and empowerment, with this position being part of Novanta’s Advanced Surgery business unit.
Matching Summary
The Lead Regulatory Affairs Specialist ensures that medical devices meet all applicable regulatory requirements and that regulatory submissions and approvals are timely performed.
Skills & Requirements
Must-have
Medical device regulatory requirements
Regulatory submissions and approvals
Design control processes
Risk management process
Clinical evaluation
Usability file
Technical documentation review
Nice-to-have
Teamwork and collaboration
Independent and self-reliant
Quality-oriented and reliable
Structured and systematic work
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