Freelance

At least 5 years of process management experience in medical projects
Experience in process establishment in accordance with certification standards: ISO 13485, IEC 62304, and ISO 14971
Extensive experience with the regulation requirements for medical software development for the U.S. (FDA) and Europe (MDR) markets
Experience in medical devices software development for Class IIb and above
Understanding of the unique challenges in healthcare process management, including regulations and stakeholder expectations
Experience in preparing medical project documentation for certification