Kartik Patel

Senior Director, Quality Assurance and Regulatory Affairs @Bravida Medical

Geneva, IL, US

Argentum Medical, Cura Surgical, BioDermKey Achievements- Silverlon silver-bullet achievement award for leading QRA department in technology transfer of silver-plating production and testing process qualifications- Overhauled QMS to meet ISO 13485:2016, MDSAP, MDD 93/42/EEC, and FDA QSR standards- Led transition from EU MDD to EU MDR for Class combinational device with medicinal substance including EMA and BSI clearance, while under budget and on-time, acquiring CE market access- Achieved CE compliance under MDD 93/42/EEC, managing remediation and successfully revoking suspension of CE certification- Hired, mentored, and developed over 15 junior/entry-level QA and RA professionals - Hosted 50+ audits (FDA, BSI ISO/CE, EMA, MDSAP, microbiological, technical, and supplier audits and clinical reviews)- Led QA and RA during acquisition and integration of 5 companies/product portfolios with various regulatory clearances- Remediated FDA 483 report- Participated as the lead QRA team member during the following merger and acquisition integration projects: • VersaLight and LightMat – Medical device used to illuminate surgical site during orthopedic procedure• TheraBond/Silverlon – OTC & Rx antimicrobial wound dressings (cutting and sterile barrier packaging)• AnaSept/SilverSept – Antimicrobial topical wound formulation products • Silver-plating production & testing technology transfer of $5M+• Ethylene oxide (EtO) sterilizer qualifications - new supplier/process integration and re-qualifications• Ongoing capital expenditure cost savings initiatives of $250K

The Ohio State University

Certificate, Nuclear Medicine - QA/RA

Gujarat University

Bachelor of Science, Pharmacy, Pharmaceutical Sciences

New Jersey Institute of Technology

Master of Science - MS, Medicinal and Pharmaceutical Chemistry