Medical Device Elk Grove
Resume:
KATHLEEN SANDOVAL, RN
Elk Grove Village, Il ***** 847-***-**** • **********@*******.***
https://www.linkedin.com/in/ksandoval09
ACCOMPLISHED MEDICAL DEVICE ANALYST
Medical Device Remediation Analyst • Medical Device Investigation Analyst • Device Analyst
Post Marketing Surveillance Analysis • Investigation Skills • Remediation of Complaints
Improved Efficiency • Reviewed Investigations • Registered Reports • Reviewed Complaints
WORK EXPERIENCE
Agilent Technologies Dec 2019 - March 2021
Remediation Investigation Analyst
●Improved efficiency by 30%.
●Reduced waiting complaints to under 2,000.
●Worked on old complaints that had not yet been investigated, reviewed, and closed.
●Worked in a new system Agile and SAP.
●Investigated information for Medical Assessments, MDR for reportability, or for closure.
Olympus Corporation June 2020 - Dec 2020
Investigation Analyst
●Served as a key contributor of the Remediation Team, effectively completing activities.
●Reviewed product complaints upon assignment.
●Determined readiness for closure and required activities pending for closure to completion.
●Ensured follow up activities were completed.
●Asked questions to support a complete complaint record to aid in investigation.
●Identified relevant additional information received in medical device reports.
●Confirmed evaluated complaints for reportability were accurate and complete.
●Confirmed when all information known was captured in FDA Form 3500A (MedWatch).
●Partnered with Engineers for modifications identified during review.
Beckman Coulter Feb 2018 - Dec 2019
Remediation Consultant
●Obtained Service Reports from the Field Service Engineers from the Oracle System for a Quality or Safety complaint.
●Registered if either was applicable information not in the gCAPA system.
●Reviewed, investigated, and closed them in gCAPA from 2018 to May of 2019.
●Obtained Service Reports for Quality or Safety complaints from the Service Max system that were not registered in Smart Solve starting in May of 2019.
●Registered applicable reports.
●Reviewed, investigated, and closed reports in the Smart Solve system.
●Collaborated with the global team to obtain incomplete information or translations of reports.
Allergan, Inc., Austin, TX Jan 2015 - Dec 2015
Safety Project Manager for Product Surveillance
●Trained and mentored coworkers for Project Surveillance.
●Prepared safety data and authored SAE narratives for regulatory submissions.
●Liaised with contracted clinical research organizations (CROs).
●Collaborated with cross functional teams including clinical operations, biostatistics, clinical development, and international teams to ensure accurate safety data was obtained and reviewed in accordance with regulatory requirements.
●Reviewed and provided input for IDE, post-market, and medical affairs protocols.
●Reviewed and provided input for the development of study specific electronic data capture (EDC) case report forms (CRFs).
●Managed and processed serious adverse events (SAEs) in compliance with protocols, ICH-GCP, ISO14155, FDA regulations, company policies and quality standards.
●Reconciled safety information for clinical and safety database locks.
Hospira, Inc., Lake Forest, IL June 2003 - Aug 2014
Global Medical Device Specialist
●Served as Regulatory Specialist with 11+ years of experience in Post Market Surveillance, working with medical device complaints in domestic and international environments.
●Coordinated and conducted medical investigations, assessments, regulatory reporting (MedWatch Reports) and follow-ups of global adverse patient events and device malfunctions.
●Reviewed regulatory authority reports for accuracy, completeness, and significant issues.
●Provided critical information to supervisors, co-workers, and subordinates by telephone, in written form, e-mail, or in person.
●Kept up-to-date technically and applied new knowledge.
●Conducted formal investigations of product complaints for infusion/critical care devices manufactured at the Costa Rica facility.
●Served as subject matter expert for investigations focusing on continuous improvement.
Prior Experience: Lutheran General Hospital, Labor and Delivery RN
EDUCATION
William Rainey Harper College, Palatine, IL
Associate of Applied Science, Nursing
TECHNOLOGIES
Trackwise, Agile, Microsoft Office, Oracle, SAP
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