BACKGROUND
FOCUS AREAS
Over 20 years of leadership experience in the medical device industry
Merger & Acquisition and Restructuring
Global Regulatory Strategies and Submissions
Quality Mangement System, Remediation, and Compliance
Operational Efficiencies and Business Transformation
As Senior Director of QMS of Eliquent Life Sciences, Kimberly McCoy provides guidance and strategy for medical device businesses related to Regulatory Affairs, Compliance, and Quality. Her leadership and expertise provides strength to the Eliquent Life Science family.
Kimberly McCoy has more than 25 years of experience in the medical device sector working on various types of medical devices including wound care, orthopedics, staplers, sutures, surgical instruments, SaMD, SiMD, and IVDs/LDTs, and NGS platforms. Her background includes product development, RA/QA, clinical, auditing, and training. She was responsible for the medical device business for one of the largest Notified Bodies managing over 400+ auditors, technical reviewers, and clinical evaluation staff globally with responsibility of the business and P&L of over $100 million. Early on her career she received her RAC and was a former Chair for the ASQ Medical Device Divsion. She currently sits on an IRB as a community member. She is fluent in English and German.
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EDUCATION:
BA in Political Science, International Relations, Texas Christian University
MBA , University of Phoenix OnlineCERTIFICATIONS:
Black Belt Certification: Syracuse University
Green Belt, JNJ
ISO 13485 Lead Auditor, Emergo
ISO 9001 Lead Auditor, Barrett International
Regulatory Affairs Certification (RAC) EU, Regulatory Affairs Professionals Society (RAPS)
Regulatory Affairs Certification (RAC) US, Regulatory Affairs Professionals Society (RAPS)ASSOCIATION MEMBERSHIPS:
ASQ Medical Device Division, Chair (20092017)
RAPS, Ohio/Indiana Chapter Founding Member (20022004) -
PROFESSIONAL & LEADERSHIP EXPERIENCE:
TṺV Rheinland, Global Vice President (Head of Medical Device Division), 2021-2022
SOPHiA GENETICS, Global Vice President RA/QA and Business Transformation, 2020-2021
KCI/Acelity (now Solventum), Sr. Manager of RA, RA Head for Surgical and Sports Medicine Division, 2016-2019AREAS OF EXPERTISE:
21 CFR 820, 806, 803, 211
ISO 13485, 14971, 9001
EU MDD/MDR
EU IVDD/IVDR
MDSAP
QMSR
ISO 27001 Information Security
ISO 14971/Risk Management
ISO 10993/Biocompatibility
ISO 19011/Auditing
ISO 17025/Calibration and Testing
IEC 62366/Human Factors
IEC 60601/Electrical Requirements
Process Validation (IQ, OQ, PQ)
CAPA
Complaint Handing/Medical Device Reporting
Production and Process Controls
Supplier Controls
Design Controls
Document Controls
Clinical Evaluation Report
Performance Evaluation Reports (IVD)
Postmarket Surveillance
IEC 62304/Software Validation
FDA 510(k)/DeNovo submissions
Technical File/Design Dossier
Technical Documentation
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