Harrison Emery Email & Phone Number

Austin, Texas, United States

My team maintains medical device regulatory intelligence for 100+ countries worldwide, available through our Regulatory Affairs Management Suite (RAMS) platform. I also provide consulting services for our medical device clients, focusing on US FDA submissions and international regulatory strategy.

I managed regulatory submissions for the On-X Prosthetic Heart Valves in APAC, working with our local teams and partners in the region to maintain compliance. I also managed the global regulatory compliance of the Chord-X Pre-Measured Loops, assisting with MDR transition and preparing worldwide regulatory submissions.

Austin, Texas Area

I worked with international teams to prepare research reports for clients on all aspects of global medical device and IVD regulations, including registration requirements, labeling, change notifications, and vigilance. I assessed global regulatory updates and communicate impacts to internal and external stakeholders. I prepared comprehensive.

Bonn Area, Germany

I was a teaching assistant for Texas A&M University students studying at the Akademie fuer Internationale Bildung in Bonn, Germany. I served as a teaching assistant for biomedical engineering courses, including differential equations, physiology, signals and systems, and medical device design.

Bryan/College Station, Texas Area

I was an undergraduate researcher in the Biomedical Device Laboratory, led by Dr. Duncan Maitland at Texas A&M University. The Biomedical Device Laboratory (BDL) develops shape memory polymer foams for aneurysm occlusion applications. I completed an undergraduate thesis in 2016 entitled "Fabrication of Shape Memory Polymer Foams with Surface-Modified.

Fremont, CA

I completed an undergraduate co-op rotation with Johnson & Johnson - Janssen R&D in the West Coast Device Development Group. Our group developed combination devices for J&J pharmaceutical products. I was responsible for writing design verification reports and FMEAs, maintaining design history files and traceability matrices, and assisting with the design.

Johnson City, Tennessee Area

I completed a summer internship at Eastman Chemical Company in the Durables and Medical Application and Development Group - Polymers Technology Division. I had responsibility for performing material durability testing and preparing troubleshooting reports for our customers.