AEKTA PATEL
Costa Mesa
Summary
A highly motivated individual with excellent leadership, great communication skills, detailed-oriented and a passion for making a positive and effective change in a prospective organization.
Overview
9
9
years of professional experience
Work History
Senior Post Market Complaints Specialist
Abiomed
02.2024 - 12.2024
- Initial review of the patient cse to determine if there was an associated complaint present in the case.
- Reviewed complaint, applied correct coding, decision tree completion and determined regulatory reporting.
- Trained to do the front end of the complaint cycle.
- Remote
Complaints Investigator
Philips
11.2019 - 12.2023
- Evaluate, investigate, track and complete complaints through an effective and established complaint handling process.
- Ensure accurate documentation of evaluation and investigation results with the assigned complaint records.
- Determine the reportability and run the decision tree in a timely manner.
- Draft the MedWatch report according to the product allegation and adverse event.
- Participate and collaborate objectively with productive conclusions in the Complaint Handling Unit meetings.
- Coordinate with the reportable complaint investigators in providing any missing information for root cause activities.
- Collaborate with Engineering, Customer Support, Field personnel, Market Service Order reviewers and other appropriate groups for adequate initial evaluation of complaints.
- Collaborate with Adverse Event Coordinators for reportable complaints as well as Product Safety Committees for Correction and Removal process.
- Work with the Post Market Surveillance for any other projects assigned
Complaints Investigator and Medical Device Reporting Specialist
Cook Medical
11.2017 - 11.2019
- Part of one of the teams which helped into lifting FDA warning letter. Cook Medical announced successful resolution of 2014 FDA Warning Letter – September 2018
- Completed Protocol CAP008 Remediation project and met the commitment given to FDA.
- Responsible of initiating and monitoring whole complaint life cycle in Trackwise from open to close which includes complaint entry, reportability decision and product failures, investigations, submitting MDRs and closing the file
- Assisting William Cook Europe team in investigating Filter complaints back log.
- Reviewed regulatory reports, and develop and coordinate responses to inquiries from regulatory authorities.
- Reviewed product complaints received from Cook global distribution centers.
- Planned, reviewed and prepared appropriate regulatory reports based on assessments.
- Generated responses to inquiries on adverse event reports from various global regulatory authorities.
- Submitted MDRs for a special remediation projects
- ACCOMPLISHMENTS:
- DUTIES:
Quality Improvement and Training Coordinator
Remington Medical INC
11.2016 - 11.2017
- Performed complaint and quality investigations related to suppliers manufacturing, design or clinical use issues.
- Reviewed and approved investigations performed by the manufacturing site or OEM supplier
- Evaluated complaints for determining MDR/Vigilance events and document rationale for not filing MDRs
- Led Qualifications, routine and for-cause audits have internal and TPOs to assess effectiveness of quality management systems
- Certified Internal Auditor to ISO 13485:2016, Title 21 CFR 801/803/806/820, CMDR SOR/98-282, EU MDR 2017/745, JPAL MHLW
- Delivered New Employee Orientation sessions after finishing their recruiting process
- Designed training assessments and keep track of learning progress of production associates to minimize the Non-conforming reports and customers complaints
- Adhere to and ensure documents compliance with Quality System SOPs, work instruction, drawings, GMPs, GDPs, ISO, and FDA requirements
Field Assurance Specialist- MDR Specialist
C.R BARD Medical Division
04.2016 - 11.2016
- Created Initial MDRs and supplemental MDRs of the products that fulfill FDA requirement
- Analyzed daily detailed reviews on MDRs in order to submit 100% accuracy to FDA
- Conducted new product registrations, complaints entering and quality medical records review received from attorney
- Ensured consistency and attention to detail in performing and reviewing medical records
- Performed final review for closure of complaint files to ensure accuracy, completeness, and attention to detail
- Assured that deadlines are met for my whole medical records and MDR team
Education
Masters - Biomedical Sciences with Organizational Development Leadership
Philadelphia College of Osteopathic Medicine
Philadelphia, PA01.2015
Bachelors - Biological Sciences
Georgia State University
Atlanta, GA01.2012
Skills
- Leadership Skills: Project Management, Research, Performance Management Systems, Organizational Development Leader, Interviewing and Recruiting, Team forming and executing, Perspective thinker, Speak multiple languages
- Software Knowledge: Quality Assurance, Trackwise 8 (FDA) and LMS, NetSuite
Timeline
Senior Post Market Complaints Specialist
Abiomed
02.2024 - 12.2024
Complaints Investigator
Philips
11.2019 - 12.2023
Complaints Investigator and Medical Device Reporting Specialist
Cook Medical
11.2017 - 11.2019
Quality Improvement and Training Coordinator
Remington Medical INC
11.2016 - 11.2017
Field Assurance Specialist- MDR Specialist
C.R BARD Medical Division
04.2016 - 11.2016
Bachelors - Biological Sciences
Georgia State University
Masters - Biomedical Sciences with Organizational Development Leadership
Philadelphia College of Osteopathic Medicine
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