Andrea Cramer

Background

About Andrea Cramer

Began career as a toxicologist in the pharmaceutical industry. Moved into the medical device industry, functioning over or as R&D, manufacturing processess/design, Tech support, RA, QC, QA, management respresentative, QMS (every element including CAPA, internal auditing, design and document controls, training), customer support. Currently in orthopedic industry, Team Lead for International Regulatory Affairs specific to Asia/Pac region (Australia, Japan, China, South Korea, SEA-Singapore, Indonesia, Thailand, Vietnam, Philippines, Malaysia, Hong Kong). Manage HQ based INTL RA team. I’ve previously managed the strategy and country prioritization of product registrations, for new and legacy product for multiple product lines - hips, knees, extremities, trauma, sports medicine, biologics, cements, and spine. And have supported new product development, internal company product changes, interactions with multiple functional departments.