Aubrey Ellis
@aubreyellis
Regulatory affairs professional bridging IVDR/FDA guidance and software quality to keep medical device filings audit-ready.
United StatesWhat I'm looking for
I’ve supported regulatory planning and compliance for 30+ in vitro diagnostic devices at IMMY, working across IVDR (EU 2017/746) and FDA expectations in areas like product, labeling, and documentation changes. I maintained regulatory deliverables and risk management files aligned with ISO 13485 and ISO 14971, and supported internal and external audits by keeping documentation accurate and traceable.
More recently at PAYCOM, I moved into software quality—supporting product changes through validation testing, controlled documentation, and change management. I’ve kept traceable records in Jira, supported deviation tracking and CAPA inputs, and helped teams stay audit-ready while meeting documented requirements and regulatory expectations.
Experience
Work history, roles, and key accomplishments
Supported product changes through validation testing, controlled documentation, and change management in a compliance-driven software environment. Maintained traceable records in Jira and supported deviation tracking, CAPA inputs, and audit readiness.
Regulatory Affairs Associate
IMMY
Apr 2022 - Dec 2023 (1 year 8 months)
Supported global regulatory planning and compliance for 30+ IVD medical devices under IVDR and FDA 21 CFR Part 820. Reviewed product and labeling changes for regulatory impact and maintained technical documentation aligned with ISO 13485 and ISO 14971.
Research Technician
Oklahoma Medical Research Foundation
Jan 2021 - Apr 2022 (1 year 3 months)
Executed laboratory experiments supporting research projects and managed equipment qualifications and calibration compliance. Collected and analyzed data to support decision-making and quality improvements.
Education
Degrees, certifications, and relevant coursework
University of Central Oklahoma
Bachelor of Science, Chemistry
Bachelor of Science in Chemistry with a minor in Biology, and a Bachelor of Science in Forensic Science.
University of Central Oklahoma
Bachelor of Science, Forensic Science
Bachelor of Science in Forensic Science.
Availability
Location
United StatesAuthorized to work in
Job categories
Interested in hiring Aubrey?
You can contact Aubrey and 90k+ other talented remote workers on Himalayas.
Message AubreyGet matched with your dream remote job
Sign up now and join over 250,000+ remote workers who receive personalized job alerts, curated job matches, and more for free!
