Nicholas Nilo

SENIOR REGULATORY affairs SPECIALIST

Nicholas is an experienced and accomplished regulatory affairs specialist working in pre-market submissions for the EU and USA. Nicholas graduated from the University of Pittsburgh with a degree in Industrial Engineering. Working with companies from 8 to 80,000 employees, Nicholas has been exposed to working with all phases of the product development cycle. He has successfully achieved CE marking for Class III neuromodulation (spinal cord stimulation) and cardiac surgery devices over the past 4 years, including cleared remediation projects for legacy devices to meet EU MDR updates. Nicholas has had success authoring US pre-market submissions including 510(k) and De Novo submissions. Working with NMCG, he has already been successful in meeting pre-market submission requirements, expectations, and timelines.

Combining a technical background, strong communication, and an eye for detail, Nicholas has had great success working to meet business interests, regulatory needs, and the realities of production.

For more information, please see his LinkedIn profile.