Araf Ahmed

About Araf Ahmed

As a Product Surveillance specialist at Abbott, I evaluate clinical complaints to determine device malfunctions\' seriousness, causality, and reportability. I ensure compliance with 21 CFR Part 803 and 21 CFR Part 820 federal regulations, collaborate with cross-functional teams to investigate clinical events, and manage product experience data for life-sustaining devices from intake to regulatory submission. A graduate of Stony Brook University with a Bachelor of Engineering in Bioengineering and Biomedical Engineering, I bring expertise in process automation, SOP, and chemical manufacturing. Dedicated to ensuring data integrity and regulatory compliance, I am motivated by the opportunity to contribute to advancements in the healthcare and biomedical fields.

Experience

1. Product Surveillance

   Abbott

   Mar 2026 — Present · Burlington, MA, US

   Evaluate clinical complaints to determine the seriousness, causality, and reportability of device malfunctions- Draft and submit FDA Medical Device Reports (MDRs) and international regulatory filings (Europe/Hong Kong) within strict legal deadlines- Ensures compliance with 21 CFR Part 803 and 21 CFR Part 820 federal regulations- Manage the end-to-end lifecycle of product experience data from initial intake to final regulatory disposition- Collaborates with cross-functional teams to investigate clinical events and maintain high-fidelity data integrity for life-sustaining products.

Education

• Red Hook Senior High School

  High School Diploma

• Red Hook Senior High School

  International Baccalaureate

• Stony Brook University

  Bachelor of Engineering - BE, Biomedical Engineering