San Carlos Park, FL, 33908
... • Oversaw global import/export documentation and regulatory compliance (IATA, FDA, HIPAA, DOT). • Monitored global inventories, retest dating, and proactively identified risks with corrective action plans. • Partnered cross-functionally with CMC, ...
- Nov 26
Hopkinton, MA
... Completed comprehensive training through Clinical Research Fastrack, gaining knowledge in FDA regulations, trial operations, informed consent, and site management. Passionate about contributing to high-quality, patient-centered studies that advance ...
- Nov 26
West Roxbury, MA
... Skilled in FDA 510(k), ISO 13485, EU MDR, and PMS processes. Founder of an AI-powered compliance platform and Co-founder of Path2RAQA, which streamlines the regulatory affairs journey & got featured in Times Square for regulatory innovation. ...
- Nov 24
Illinois
... and Assessment, ASQC Communicative Manager Course En 46001, GMP, and FDA training course Continuous Improvement of process course Problem Solving training workshop course Design of experiment APQP, PPAP, FMEA, DOE, and PFMEA courses and training. ...
- Nov 24
Philadelphia, PA
... Safety Narratives Investigators Brochures Periodic Update Safety Reports Marketing Authorization Applications Responses to FDA Questions Medical Device CERs Updates to SOPs Education MA Clinical Psychology, University of Pennsylvania, Philadelphia, ...
- Nov 24
Anaheim, CA
... Experienced in FDA 510k submissions, EU-MDR Gap Mitigation’s. GMP, TUV, MATLAB, SPC, SIX SIGMA and ISO 9000, ISO 14971, ISO 13824, and ISO 13408. Product verification IQ, OQ, PQ. Hydro coater 4up and 8up automation design, and assembly utilizing ...
- Nov 24
Philadelphia, PA
... high priority change controls needed for production Provided reports and documents per audit requests, both internal and FDA Process, distribute and file Raw Material and Finished Product Test Methods & Analytical Reports Issue and track process ...
- Nov 24
Toronto, ON, Canada
... verification test environments and tools to enable efficient test execution Evaluated and validated QA compliance with FDA and ISO regulatory standards (system verification, risk controls, and audit readiness) Served as a technical advisor in ...
- Nov 24
Las Vegas, NV
... Bryan Bachar COMMERCIAL San Disk Supporting True Movement/Jordan Pope Donor Network West Supporting Three Sticks/Al Polito FDA Principle Nvisionate Studios Lancer Skin Care Principle Script-to-Screen/C.Gudvangen Luminess Air Brush Principle Really ...
- Nov 23
Columbus, OH, 43211
... Proven record leading high-volume implant programs with full FDA compliance, building cross-functional training programs in hospital settings, and evaluating/operating commercial properties. Currently expanding capabilities in AI and prompt ...
- Nov 23