Theresa Glass
Regulatory Affairs Specialist @Intech
Kenosha, WI, US
EMAILS
MOBILE NUMBERS
+91 *********19
Signup · Get unlimited contacts
WORK HISTORY
Apr 2021 — Present
Regulatory Affairs Specialist @Intech
View department →
US
Regulatory Affairs (Senior) Specialist Assisted and developed a EUMDR compliant documents and procedures, determine classification and review Technical files, IFUs and Clinical Evaluation Reports. Trained RA personnel, and R&D personnel. Executed submissions for class 1r, FDA class 1. In addition, Product Registration, UDI assignment, PMS Strategy, contact material status, provide regulation guidance to staff and management. Lead EUMDR and ISO 13485 Auditor.
EDUCATION
1981 — 1994
Illinois Institute of Technology
Bachelor of Science (B.S.), Biology, General
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.