Introduction + Regulatory Foundations
Set the foundation for how we will research, interpret and discuss regulatory requirements together.
It is not just about learning regulations—it is about building meaningful, real connections with people across the globe.
Did you know? Cohort 2 already has registrations from the United States, United Kingdom, Switzerland, Canada and India.
When I was preparing for RAC-Devices, I kept wishing for a space that felt both structured and human—a place where I could learn with others instead of studying alone.
I wanted the opportunity to explore a topic deeply enough to present it, ask questions without hesitation, hear how experienced professionals interpret the same requirements, and still leave room for curiosity and a little fun. Most of all, I wanted a community where each of us could be both a mentor and a mentee.
That is the intention behind these cohorts: to make learning collaborative, practical and personal. If this space helps even one person feel more confident, make one meaningful connection or move one step closer to their goal, it will have fulfilled its purpose.

Begin Cohort 2 with an opportunity to learn, ask questions and connect during our introductory session on October 3.
View Linda Bowen on LinkedInThe structure broadly aligns with RAC-Devices topics while going beyond examination preparation into practical regulatory discussion.
Set the foundation for how we will research, interpret and discuss regulatory requirements together.
Explore FDA frameworks, pathways and applied questions through participant research and guided discussion.
Work through EU MDR expectations, technical documentation and practical interpretation.
Compare pathways and discuss how regulatory strategy changes across global markets.
Expect participant-led research, Kahoot quizzes, question-bank discussions, practical regulatory files, real-world examples and guest conversations.
I am a Regulatory Affairs professional with experience across Class II and III medical devices, U.S. FDA, EU MDR and global lifecycle activities.
My background spans Abbott, Tata Elxsi/Zimmer Biomet, regulatory consulting and biopharma R&D. These cohorts bring together the scientific, regulatory and human sides of professional growth.
Explore reflections from the earlier cohort and see what collaborative learning meant to the people who joined.
Each cohort is intentionally kept small. Join the priority waitlist to hear about the next cohort before registration is published online.
There is no payment required to join the waitlist. Seats are confirmed separately after registration and payment.
Join the priority waitlistFor cohort questions, mentoring enquiries, guest contributions or future partnership opportunities, I would be glad to hear from you.
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