Lindsey Sheppard
Medical Device Consultant
- Role
- Consultant - Sr Technical Writer at USDM Life Sciences
- Location
- Dallas, TX, US
- LinkedIn followers
- 500 followers
About Lindsey Sheppard
Driving results with integrity, rapid change, strategic thought, meaningful relationships and effective communication. QMS Expertise: Regulatory Affairs (Reporting + EU MDR Compliance), Post Market Surveillance (Complaints + CAPA), Quality Engineering (Labeling/UDI + Data Analytics + Risk Management).
Experience
Consultant - Sr Technical Writer
Sep 2019 — Present
Hologic - Sr. Technical Writer for EU MDR Compliance. Assessed, redlined and released approximately 200 EU MDR compliant QMS/PMS documents- Terumo BCT - Sr. Technical Writer for Global Business Harmonization & EU MDR Compliance. EU MDR gap analysis for QMS policies and procedures. Assessed, redlined and released approximately 150 EU MDR compliant documents in Labeling, PMS, UDI, IFU and Risk Management subcategories.
Education
Illinois Institute of Technology
Bachelor of Science - BS
Florida Gulf Coast University
Bachelor’s Degree
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