Allen Chen

Allen Chen, Ph.D. is a biomedical engineer and regulatory affairs professional with extensive experience in the medical device industry.1 He recently transitioned from his role as Program Manager at the FDA's Center for Devices and Radiological Health (CDRH) to a position as Manager of Biosurgery Regulatory Affairs at Johnson & Johnson in October 2022.12

During his tenure at the FDA from 2015 to 2022, Chen held several positions, including:

• Program Manager (August 2019 - October 2022)
• Acting Assistant Director (November 2021 - March 2022)
• Lead Medical Device Reviewer (September 2016 - August 2019)
• AIMBE-FDA Scholar (October 2015 - September 2016)1

Chen's educational background includes:

• Ph.D. in Bioengineering/Biomedical Engineering from Rice University
• B.S. in Bioengineering with an Undergraduate Business Minor from Rice University1

He has received numerous certifications and awards, including:

• Project Management Professional (PMP) certification
• Certified Quality Auditor (CQA)
• FDA Outstanding Service Award
• FDA Honor Award
• FDA Commissioner's Special Citation1

Chen's LinkedIn profile username is allen-chen-b00b252a, as mentioned in the query.