Janea Weaver
Chicago
Summary
Experienced Medical Device/Pharmacovigilance professional with over 10 years of experience in the pharmaceutical industry specializing in medical review, complaint handling, MDR reporting, quality control, quality assurance, documentation management, and regulatory. My goal is to ensure the highest quality outcomes possible.
Overview
12
12
years of professional experience
Work History
Global MDR Submissions Analyst II
Olympus Corporation of the Americas
10.2023 - Current
- Ensure Regulatory Excellence: Assist with drafting and review of Medical Device Reports (MDRs), eMDRs, and global vigilance reports (e.g., PDMA) with precision and clinical insight.
- Review incoming complaints related to medical devices, assess the facts, and verify information from various sources.
- Conduct timely initial and re-assessments of complaints to determine if they are reportable to regulatory bodies (e.g., FDA) according to established guidelines and regulations.
- Prepare and submit MDR reports and supplemental reports to regulatory agencies, ensuring accuracy and completeness of the information.
- Collaborate with internal teams (e.g., Global MDR Submission Management, Field Specialists, Engineers) and external stakeholders (e.g., regulatory agencies) to resolve issues and ensure efficient processes.
- Maintain a thorough understanding of global regulatory requirements for medical device reporting, including FDA regulations (e.g., 21 CFR Part 803, 21 CFR Part 820) and ISO 13485.
- Conduct clinical assessments for complex complaints and as requested by management.
Medical Reviewer/Safety Reviewer II
AbbVie
02.2022 - 12.2022
- Evaluated, processed, and monitored clinical product complaint handling for clinical medical devices in accordance with 21 CFR Part 803.
- Collaborated with CRAs, vendors and manufacturers and SMEs to obtain accurate and additional information related to Adverse Events.
- Completed reviews for MDRs & FARs submissions to FDA; teamed with PPS safety team to accurately measure reportability.
- Maintained and tracked complaints log.
Project Coordinator
Fresenius-Kabi
01.2019 - 10.2019
- Lead team meetings with project members to ensure schedules, resources and information were available and accessible.
- Supported project documentation by managing, collecting, creating, modifying and collating documents into one shared location.
- Retrieved documents and records for project departments.
- Served as a point of contact or project SME for document retrieval and project completion timeline.
QA Associate
EdgeOne Medical
11.2018 - 12.2018
- Reviewed documents, records and reports for accuracy and compliance against SOPs.
- Ensured out-standing CAPAs were closed out and implemented.
- Managed non-conforming material and dispositions.
- Processed and initiated investigations related to medical devices.
- Issued, reviewed and approved change controls adhering to current QMS standards.
QA Associate
Avexis, Inc.
04.2018 - 10.2018
- Collaborated with manufacturing bioengineers to revise and review master batch records and SOPs.
- QA audit of documentation records and reports against appropriate SOPs against QMS standards.
- Assisted and tracked CAPA investigations and ensured affected processes and product continued to meet requirements.
Technical Writer/Document Specialist
Fresenius-Kabi
05.2016 - 12.2017
- Responsible for technical writing and coordinating documentation required for packaging design changes in conjunction with Regulatory Affairs.
- Managed and maintained multiple documentation change processes with Quality team to review and revise master batch records.
- Coordinated with department managers to ensure accuracy of revised documentation.
- Initiated change control requests; collaborated with medical device division for processing product complaints and MDR submission reports.
Quality Control Analyst
Blistex, Inc.
03.2015 - 12.2015
- Responsible for technical writing and coordinating documentation required for packaging design changes in conjunction with Regulatory Affairs.
- Managed and maintained multiple documentation change processes with Quality team to review and revise master batch records.
- Coordinated with department managers to ensure accuracy of revised documentation.
- Initiated change control requests.
Quality Control Analyst
Fresenius-Kabi
04.2014 - 03.2015
- QA reviewed testing procedures and protocols according to SOP standards for accuracy and compliance.
- Stream-lined deviation impact by analyzing, processing and conducting investigations for non-conformances and CAPAs to ensure the best quality product.
- Maintained documentation management through effective record monitoring and tracking.
- Teamed cross-functionally with the medical device division for evaluating and processing complaints adhering to 21 CFR Part 803.
Education
B.S. - Biology
Roosevelt University
05-2008
A.A with Honors - General Studies
Harold Washington College
05-2005
Skills
- Complaint Handling
- Medical Device Report Submissions
- CAPA Investigations
- Regulatory
- Quality
- Documentation and reporting
- Root-cause analysis
- Compliance analysis
- Regulatory compliance
- Time management
- Analytical thinking
Timeline
Global MDR Submissions Analyst II
Olympus Corporation of the Americas
10.2023 - Current
Medical Reviewer/Safety Reviewer II
AbbVie
02.2022 - 12.2022
Project Coordinator
Fresenius-Kabi
01.2019 - 10.2019
QA Associate
EdgeOne Medical
11.2018 - 12.2018
QA Associate
Avexis, Inc.
04.2018 - 10.2018
Technical Writer/Document Specialist
Fresenius-Kabi
05.2016 - 12.2017
Quality Control Analyst
Blistex, Inc.
03.2015 - 12.2015
Quality Control Analyst
Fresenius-Kabi
04.2014 - 03.2015
B.S. - Biology
Roosevelt University
A.A with Honors - General Studies
Harold Washington College