Olisha Booker

Master's

Health Information Technology

Alchemix a Nitro Quimica Company

Regulatory Specialist

- Knowledge and experience with ISO 9001, FDA 21 CFR Part 210/211, 807,820, Part 11, UL/GRMA certification, cGMP/GxP - Established and maintained Device Master Records and other compliance documentation - Review and submit compliance documentation to appropriate regulatory bodies - Led internal and external customer audits and CAPA program planning, submission, and evaluation - Investigate non-conformance /deviation events using root cause analysis tools - Submitted regulatory filings to the FDA/EU and handled follow-up responses /actions - Responsible for 510k submission for new medical device products and OTC drugs