Christopher Collins
principal consultant
Chris Collins has over 20 years of large-organization medical device experience, focusing on Class II and Class III vascular devices, and is very comfortable working with both large and small organizational structures in new product development and commercialization.
Chris began his career in Research and Development, focusing on the product development of peripheral vascular devices. During this time Chris was responsible for developing and implementing product test strategies, failure mode analyses, test methodology, and design transfer activities. Transitioning to Regulatory Affairs, Chris took on roles with increasing responsibility in Coronary product development and commercialization, including the planning and implementing Clinical Investigation of cutting-edge combination products within the United States – often managing several Pre-Submission interactions with the US FDA. Additionally, Chris managed multi-module, combination product PMA filings from planning through approval and the transition of Regulatory Responsibilities from one business group to another.
Chris also has extensive experience with Rest-of-World (ROW) product submissions, including working with local geographic partners to strategize, develop, and create filings for global regulatory authorities including Japan, Brazil, and European Notified Bodies. Chris has also led remediation activities to transition a broad product portfolio from the European Medical Device Directive to the European Medical Device Regulations.
Chris has worked closely with multiple functional disciplines including R&D, Quality Engineering, Manufacturing Engineering, Clinical, Legal, and Marketing staff. He has a deep understanding of the development, review, and approval of product development documentation, manufacturing and/or documentation changes (with a focus on regulatory reporting requirements), and promotional materials.
Chris pursues several passions outside of consulting including biking, hiking, photography, and golf. He is based in the wine country region of Sonoma County, California.
For more information, please see his LinkedIn profile.