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Invitation Only
Invitation Only
Separate Ticket or Advanced Registration Required
Separate Ticket or Advanced Registration Required
Repeat Solutions Circle
Repeat Solutions Circle

Colin S. Jacob, MS

Product Management + Regulatory Affairs Professional
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Colin Jacob, MS, is a product management and regulatory affairs professional with a decade of experience in medical device and AI software sectors. He has worked across both premarket and postmarket phases in some of the world’s most regulated healthcare markets, engaging directly with authorities including US FDA, Health Canada, Notified/Approved Bodies (EU and UK), ANVISA (Brazil), PMDA (Japan), NMPA (China), and TGA (Australia). His experience spans global submissions, compliance audits, and evolving AI/ML frameworks, including FDA’s Predetermined Change Control Plans (PCCPs), EU MDR, and the EU AI Act.

In his recent roles, Colin led global initiatives focused on market expansion, competitive intelligence, and regulatory strategy for AI-enabled healthcare technologies. He blends deep regulatory knowledge with product strategy to guide cross-functional teams and navigate complex go-to-market pathways.

A dedicated RAPS volunteer for 10 years, Colin currently serves as Chair of the RAPS Membership Committee. In this role, he helps shape products and services that strengthens the value of RAPS membership for all regulatory professionals. He began his journey with RAPS as a Student Ambassador at Convergence and now returns as a speaker and leader.

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