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Fernanda C. Email & Phone Number
Global MDR Submission Analyst II
at
Olympus Corporation of the Americas
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✓ Verified May 2026
3 data sources
Profile completeness 86%
Current company
Role
Global MDR Submission Analyst II
Location
United States, United States, United States
Company size
Who is Fernanda C.? Overview
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Quick answer
Fernanda C. is listed as Global MDR Submission Analyst II at Olympus Corporation of the Americas, a company with 13431 employees, based in United States, United States, United States. AeroLeads shows a matched LinkedIn profile for Fernanda C..
Fernanda C. previously worked as Regulatory Post Market Surveillance at Intuitive and Complaint Specialist at Bd. Fernanda C. holds Executive Mba, International Business from Texas A&M International University.
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Olympus Corporation of the Americas
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Profile bio
About Fernanda C.
Fernanda C. is a Global MDR Submission Analyst II at Olympus Corporation of the Americas.
Current workplace
Fernanda C.'s current company
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Olympus Corporation Of The Americas
8 roles
Fernanda C. work experience
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Global Mdr Submission Analyst Ii
Current
Sep 2023 - Present
Regulatory Post Market Surveillance
- Evaluate complaints for reporting requirements per company procedures and Regulatory requirements.- Perform Failure Analysis investigation review. - Evaluate documentation for completeness and consistency, and assign additional actions as necessary to close the complaint file. Approve final complaint file for closure after all applicable actions are.
Feb 2023 - Sep 2023
Complaint Specialist
- Receive and review the content of product complaints provided by patients, healthcare professionals, clinicians, sales representatives, case studies, and literature. - Check for complaint accuracy and proceed with complaint determination, data entry, reportability decisions, and MDR filing.- Enter and maintain complaint records following FDA medical.
Jan 2022 - Aug 2022
Quality Technician 3 - Complaint Investigations
- Perform complaint investigations utilizing physical medical device evaluation methods, material characterization testing, documentation evaluation and simulated use testing in order to establish a probable root cause and failure mode associated with a reported complaint event.- Ensure compliance with appropriate laws and regulations relevant to the job.
Aug 2018 - Jan 2022
Product Surveillance Rep, Sr. - Intl. Team
- Investigated and maintained complaint files from Latin America, Canada, and APAC, following complaint handling regulation 21 CFR 820.198 and internal procedures. - Analyzed information obtained and made decisions for reportability under MDR regulation, 21 CFR 803, and international regulations.- Conducted regulatory reporting per applicable regulations.
Apr 2016 - Jul 2018
Fraud Specialist - Intl. Support
-Reviewed and analyze online orders looking for fraudulent activity.-Contacted credit card companies, banks, and customers to verify charge activity.-Assisted customers with their fraud concerns.
Feb 2015 - Mar 2016
International Purchasing
Artefacto S/A
-Placed orders with suppliers from Brazil, Europe and Asia.-Negotiated prices and coordinate deliveries.- Initiated and followed-up all imported shipments working closely with vendors, freight forwarders and customs brokers. -Checked all shipment received and followed up with suppliers.
Sep 2012 - Oct 2014
3 education records
Fernanda C. education
Executive Mba, International Business
Business Analytics
Bachelor'S Degree, Biology/Biological Sciences, General
FAQ
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What company does Fernanda C. work for?
Fernanda C. works for Olympus Corporation of the Americas.
What is Fernanda C.'s role at Olympus Corporation of the Americas?
Fernanda C. is listed as Global MDR Submission Analyst II at Olympus Corporation of the Americas.
Where is Fernanda C. based?
Fernanda C. is based in United States, United States, United States while working with Olympus Corporation of the Americas.
What companies has Fernanda C. worked for?
Fernanda C. has worked for Olympus Corporation Of The Americas, Intuitive, Bd, Smith & Nephew, and Allergan.
How can I contact Fernanda C.?
You can use AeroLeads to view verified contact signals for Fernanda C. at Olympus Corporation of the Americas, including work email, phone, and LinkedIn data when available.
What schools did Fernanda C. attend?
Fernanda C. holds Executive Mba, International Business from Texas A&M International University.
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