Maritza Ward, RAC

Maritza Ward serves as an RA/QA Advisor for Pearl Pathways with over 20 years of experience as a regulatory affairs and quality assurance professional in the pharmaceutical and medical device industries.

Maritza specializes in developing global regulatory strategies for moderate and high-risk devices, drafting regulatory submissions, and developing IMDRF compliant STED files. She is proficient with technical and regulatory writing, and has authored numerous 510(k)s, PMAs, IDEs, Q-submission requests, Breakthrough Device Designation Requests, 513(g)s, international registrations, and significant change notices.

Maritza is a certified ISO 13485:2016 Lead Auditor. She is well versed in medical device and pharmaceutical QSR, GMP and GCP requirements including 21 CFR §50, §54, §56, §211 §803, §820, ISO 13485 and ICH E6, and has significant experience with leading and participating as a subject matter expert in internal and external audits covering these requirements. Maritza holds a B.S. in Biochemistry from the University of California, San Diego.