Shakia Smith
Product Surveillance Senior Specialist at Zimmer Biomet
- Role
- Product Surveillance Senior Specialist at Zimmer Biomet
- Location
- Atlanta, GA, US
- LinkedIn followers
- 500 followers
About Shakia Smith
Driven and detail-oriented individual with over five years of regulatory, quality, and…
Experience
Product Surveillance Senior Specialist
Dec 2019 — Present · Warsaw, IN, US
Adheres to all corporate and site specific procedures- Identifies and investigates solutions to procedure and process related issues- Revises the procedure or process as needed to increase efficiency and compliance- Provides vision, direction and strategy for patient safety in the Post market process- Documents and maintains records in accordance with corporate and site specific procedures- Creates, maintains and monitors appropriate metrics to measure key performance indicators of the unit- Creates and provides continuous update of Reportability Guidance Document to ensure consistency throughout the organization- Responsible for accurate medical rationale and judgment- Reviews and approves MDRs, MEDDEVs, and other regulatory inquiries- Reviews medical/operating records for medical judgment on reportability- Provides direction to internal and external personnel on issues related to the defined steps/process- Performs complaint follow-up/due diligence with healthcare professionals, sales representatives, etc. to obtain all objective evidence for the complaint file- Facilitates meetings to ensure target metrics are met.
Education
The George Washington University School of Business
Master of Business Administration - MBA
2018 — 2020
Georgia State University
Graduate Certificate in Public Health, Public Health/ Epidemiology
2014 — 2016
Georgia Southern University
Bachelor of Science (BS), Chemistry
2009 — 2013
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