Olivia Ellis
Cleveland
Summary
Senior PMS specialist with a strong background in complaint remediation and regulatory compliance within the medical device industry. Proficient in ETQ and TrackWise, driving effective solutions and fostering cross-functional collaboration. Experienced in preparing timely MDR submissions and enhancing audit readiness through analytical skills and effective communication.
Overview
12
12
years of professional experience
Work History
Senior PMS Specialist, Consultant
Abiomed
01.2024 - Current
- Led complaint remediation efforts, aligning legacy records with regulatory requirements to enhance compliance.
- Evaluate customer complaints for MDR reportability in accordance with 21 CFR 803.
- Prepare, review, approve, and submit initial and supplemental MDRs within required timelines.
- Develop well-supported rationales for non-reportable events.
- Ensured completeness and audit-readiness of complaint files in EtQ, facilitating regulatory audits.
- Collaborated cross-functionally to gather additional information for final submissions, improving report accuracy.
Senior PMS Specialist, Consultant
ICU Medical
01.2022 - 01.2023
- Prepared and submitted MDRs, MIRs, and global regulatory reports, supporting adherence to regulatory requirements.
- Determined global reportability using regulatory decision trees, facilitating compliance with international standards.
- Managed complaints from intake through closure, ensuring timely resolution and stakeholder communication in Agile.
- Applied appropriate coding and ensured investigation documentation met quality standards.
Quality Engineer, Consultant
Zimmer Biomet
01.2021 - 01.2022
- Delivered analytical support for global complaints, CAPAs, and field actions to enhance resolution processes.
- Developed and analyzed Market History Reports and complaint searches to identify trends and inform quality improvements.
- Facilitated audit preparation and mentored new team members to strengthen team capabilities and compliance.
EU MDR Recoding Specialist, Consultant
Philips
01.2019 - 01.2021
- Remediated complaints, ensuring compliance with EU MDR and IMDRF coding requirements.
- Partnered with PMS and Risk Management to enhance trending and compliance reporting processes.
Post Market Surveillance Specialist, Consultant
Beckman Coulter
01.2019 - 12.2019
- Conducted complaint investigations utilizing root cause methodologies to identify and address product issues.
- Prepared MDR/MIR submissions for FDA and international authorities to ensure regulatory compliance.
Regulatory & PMS Roles
Zimmer Biomet
01.2017 - 01.2018
- Evaluated complaints for reportability, ensuring compliance and initiating timely remediation actions.
- Prepared and submitted initial and supplemental MDRs to meet regulatory deadlines and maintain product safety.
- Supported updates to technical files and GUDID submissions, facilitating successful audit preparation and regulatory adherence.
Complaint Handling Specialist
Invacare Corporation
01.2016 - 01.2017
- Investigated complaints and evaluated events to ensure compliance with regulatory reporting requirements.
- Recommended process improvements aligned with FDA guidelines to enhance complaint handling processes.
- Trained new staff on safety protocols and operational procedures.
Customer Service Specialist
Teleflex Medical
01.2014 - 01.2016
- Coordinated execution and regulatory documentation of product recalls to ensure accurate processing and audit-ready closure.
- Facilitated communication between Customer Service and Regulatory teams.
Education
Bachelor of Arts - Psychology
William Peace University
Raleigh, NC05.2014
Skills
- Time management
- Effective communication
- Attention to detail
- Team leadership
- Training and mentoring
- Complex problem solving
- Complaint resolution
- Regulatory reporting
- Data analysis
- Cross-functional collaboration
- Root cause analysis
- Global compliance
- Audit preparation
Software And Systems
- SmartSolve
- TrackWise
- Agile
- EtQ
- OnBase
- SAP
- Oracle
- Tableau
- Microsoft Office
- SharePoint
Timeline
Senior PMS Specialist, Consultant
Abiomed
01.2024 - Current
Senior PMS Specialist, Consultant
ICU Medical
01.2022 - 01.2023
Quality Engineer, Consultant
Zimmer Biomet
01.2021 - 01.2022
EU MDR Recoding Specialist, Consultant
Philips
01.2019 - 01.2021
Post Market Surveillance Specialist, Consultant
Beckman Coulter
01.2019 - 12.2019
Regulatory & PMS Roles
Zimmer Biomet
01.2017 - 01.2018
Complaint Handling Specialist
Invacare Corporation
01.2016 - 01.2017
Customer Service Specialist
Teleflex Medical
01.2014 - 01.2016
Bachelor of Arts - Psychology
William Peace University