FDA Resumes

Wilton, CT
... Expert in trial design, regulatory submissions (IND, IDE, 510(k), PMA), CRO/vendor oversight, and FDA engagement. Board-appointed IRB member and cross-functional team leader with credentials in five medical and two regulatory specialties. Core ... - Feb 21

India
... ■ With more than 20,000 drugs approved by FDA in the US, testing adverse reactions to drug interactions with wet tests is expensive. Adverse reactions cost the US $136B annually. ■ Built Ensemble model comprised of graph neural networks (GNN) ... - Feb 21

Lancaster, PA
... 04/2023 – 07/2023 Quality Consultant – Assessment of adequacy of Quality Systems (CAPAs, Change Control, Complaints, Annual Product Review) to ensure alignment and compliance with company corporate policies/FDA requirements and INVIMA requirements. ... - Feb 20

Ontario, CA
... • Hand tools • Mathematical aptitude • GPS • Supply chain management • Packaging • Lead generation • Warehouse Experience • FDA regulations • Management • Manufacturing facility • Grocery store • Organizational skills • Sterilization • Warehouse ... - Feb 20

Pearland, TX
... Proven expertise in adhering to AAMI, AORN, FDA, and OSHA standards while managing decontamination and infection prevention protocols. Successfully operated sterilization machinery including autoclaves and V-Pro, ensuring precise sterilization ... - Feb 20

Longmeadow, MA
... • Record keeping • Data collection • Root cause analysis • Leadership • Microsoft Outlook • Retail sales transactions • FDA regulations • Heavy lifting • Pesticide dusting • Manufacturing company experience • Math • Interpersonal communication • ... - Feb 20

Silver Spring, MD
... Provided non-clinical and regulatory arena audits, lab protocols, CRF design and guidance with the FDA. Director National Sales, SGS Life Sciences, Rutherford, NJ 04/2013-08/2013 Directed the large molecule program, working with Pharmaceutical, ... - Feb 20

Atlanta, GA, 39901
... Extensive product knowledge or the ability to obtain product knowledge FDA Inspector THERMO PAAC Stone Mountain, GA 2014-2017 Inspect out dock products to insure they meet lawful standards Conduct regular scheduling of outbound products to U.S. ... - Feb 19

Memphis, TN
... Plant Manager – FDA-Regulated Distribution & Warehousing Quala – West Memphis, AR February 2019 – August 2021 Directed FDA-regulated operations requiring high accuracy, traceability, and audit integrity. Strengthened process discipline impacting ... - Feb 19

Schaumburg, IL
... ●Selected to implement and lead efforts to broaden RWS AI machine language translation functionality in Veeva RIM and PromoMats, including creating validation test cases, new SOPs for FDA ICH submissions, and product-labeling translation requests; ... - Feb 18