Michele McDonald
Medical Device Design Assurance expert
- Role
- Global Compliance Lead, Medical Devices at Church & Dwight Co., Inc.
- Location
- Milwaukee, WI, US
- LinkedIn followers
- 500 followers
About Michele McDonald
o 35+ years deep domain engineering, manufacturing & analytical expertise in medical device QMS & life-cycle operationso Accomplished Executive and strategic leader introducing and improving medical device productso Project leader, talent acquisition and compliance coach for large remediation projectso Effective cross-functional consultant management for extensive range of medical devices and supply chain technologieso EU MDR certification, 510k/PMA submissions Independent Reviewer for Class I, II & deviceso Risk management, consensus standard verification, product liability expert witnesso Merger & Acquisition due diligence for device design, quality and regulatory systemso Warning Letter close-out, 483 responses, Recall execution & Consent Decree remediationo Manage inspection readiness and execution for global competent authorities and Notified Body certificationso Regulatory intelligence for global medical device products, trends & enforcemento Strong analytical practices, investigation methods and data system validationso Applied expertise in MDSAP, 21 CFR 803, 806 & 820, ISO 13485 & 14971 and EU MDR 2017/745o Extensive QMS data system design and integration with CAPA, Post Market & Supply Chain systems
Experience
Global Compliance Lead, Medical Devices
Dec 2022 — Present · US
Education
Southern Illinois University, Carbondale
BSIT, Engineering - Industrial Technology
Skills
- Process Improvement
- Fmea
- Regulatory Affairs
- Mdr
- Quality Assurance
- Post Market Surveillance
- U.s. Food and Drug Administration (Fda)
- Product Development
- Quality System
- V&V
- Gmp
- Complaint Management
- Validation
- 21 Cfr Part 11
- Iso 13485
- Standard Operating Procedure (Sop)
- Glp
- Medical Devices
- Quality Management
- Capa
- Dmaic
- Regulatory Submissions
- Testing
- U.s. Title 21 Cfr Part 11 Regulation
- R&D
- Quality System Compliance
- Research and Development (R&D)
- Gxp
- Quality Auditing
- Change Control
- Fda Gmp
- Risk Management
- Root Cause Analysis
- Computer System Validation
- 21 Cfr
- Regulatory Requirements
- Iso
- Corrective and Preventive Action (Capa)
- Business Process Improvement
- Sop
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