Tee Pamon, PhD is Senior Regulatory Affairs Consultant at AlvaMed. Tee brings more than ten years of medical device regulatory experience spanning specialties including spine, orthopedics, sports medicine, dental, and neurology. He has extensive experience working with synthetic, metal and animal-derived implants, surgical instrumentation, and enabling technologies. He has served in regulatory and clinical affairs roles in both mid-sized and large Fortune 500 MedTech companies.
Over the course of his career, Tee has:
Regulatory Affairs
- Led and authored successful FDA and EU MDR submissions and served as the primary regulatory interface with FDA and Notified Bodies throughout the review process.
- Developed and executed global regulatory strategies, supporting submissions and market access across the US, EU, UK, Canada, Australia, Japan, Singapore and China.
- Advised engineering, quality, marketing, clinical, and operations teams on regulatory requirements throughout product development, design changes, labeling, and commercialization activities.
- Served as labeling subject matter expert within the organization, developing labeling for new products, and assessing changes to existing labeling.
Clinical Affairs
- Identified clinical data gaps in the company’s orthopedics and sports medicine portfolio.
- Developed and executed strategies for clinical evidence generation to ensure compliance with EU MDR requirements.
- Reviewed a wide range of Clinical documentation including Clinical evaluation reports (CERs), Post Market Clinical Follow-up (PMCF) plans and reports, Periodic Safety Update Reports (PSUR), and Summary of Safety and Clinical performance (SSCP).
Tee holds a BS and PhD in Biomedical Engineering from Stony Brook University and a Master of Engineering in Biomedical Engineering from Cornell University.
