Natalia Gerrald
Irmo,SC
Overview
6
6
years of professional experience
Work History
Global MDR SUBMISSIONS ANALYST II
Olympus Medical
01.2023 - Current
- Managed MDR submissions for global medical devices, ensuring compliance with FDA and global regulatory requirements (21 CFR Part 803).
- Worked directly with Product Focus Teams as a Subject Matter Expert (SME) on regulatory processes for MDR reporting, ensuring consistency across product lines.
- Ensured accurate regulatory assessments of complaints and events, collaborating with cross-functional teams to determine the need for initial or supplemental MDR reports.
REGULATORY AFFAIRS SPECIALIST II
Intuitive Surgical, Inc.
04.2022 - 01.2023
- Supported the backlog remediation of regulatory submissions and compliance activities for robotic surgical systems, ensuring adherence to FDA, EU MDR, and global regulations.
- Conducted reportability assessments for reportable malfunctions and adverse events; preparing and submitting eMDR submissions.
POSTMARKET SURVEILLANCE ANALYST II
Phillips, Respironics Division
09.2021 - 04.2022
- Worked with the complaints handling team to investigate and report adverse events related to respiratory equipment.
- Consistently met or exceeded performance metrics in areas such as complaint investigation and complaint closures.
QUALITY ASSURANCE SPECIALIST II
Agilent Technologies
03.2020 - 09.2021
- Supported quality assurance (QA) and regulatory compliance for medical devices, specifically in the field of IVD (in vitro diagnostics)
- Supported quality assurance (QA) and regulatory compliance for medical devices, specifically in the field of IVD (in vitro diagnostics).
MDR VIGILANCE SPECIALIST
Beckman Coulter, Inc.
11.2018 - 12.2019
- Managed complaints handling, including adverse event reporting for Hematology devices and whole blood calibrators and controls.
- Conducted MDR submissions and ensured that reportability assessments were conducted in line with FDA and global regulatory requirements.
Education
Certification - Management, Credential of Readiness (CoRE)
Harvard Business School Online
02-2015
Bachelor of Science - Biological Sciences
Florida International University
Miami, FL05-2009
Skills
- Backlog Reduction/Remediation
- FDA Class II & III MDR Submissions
- MS Office Applications
- Power BI
- Good Documentation Practices
- Statistical Analysis
- Process and Design Controls
- QMS: Agile
- TrackWise/TrackWise Digital
- GCAPA
- Oracle
- SmartSolve
- SalesForce
- ETQ Reliance
Timeline
Global MDR SUBMISSIONS ANALYST II
Olympus Medical
01.2023 - Current
REGULATORY AFFAIRS SPECIALIST II
Intuitive Surgical, Inc.
04.2022 - 01.2023
POSTMARKET SURVEILLANCE ANALYST II
Phillips, Respironics Division
09.2021 - 04.2022
QUALITY ASSURANCE SPECIALIST II
Agilent Technologies
03.2020 - 09.2021
MDR VIGILANCE SPECIALIST
Beckman Coulter, Inc.
11.2018 - 12.2019
Certification - Management, Credential of Readiness (CoRE)
Harvard Business School Online
Bachelor of Science - Biological Sciences
Florida International University
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