Medical Device Consultant/Administrative

Carla E. Perkins 727-***-**** – *************@*****.***

SUMMARY

Successful Microsoft Certified Professional and Salesforce Administrator with solid analytical skills seeking a new opportunity in a collaborative work environment where I make a valuable contribution. Completed AS degree in Health Information Technology September 2021.

TECHNICAL SKILLS

Microsoft Office

SmartSolve

Oracle

gCAPA

Sharepoint

ClientSpace

Salesforce

Crystal

ReportSmith

SAP

PeopleSoft

Citrix

Pilgrim Software

EasyTrak

TrackWise

Catsweb

Echo

Agile

EXPERIENCE

Advantage Technical, Medical Device Consultant 08/25- 11/25

Analyze and process complaints in a uniform and timely manner, to ensure proper complaint coding and accurate complaint assessment. Perform data entry and prepare reports / graphs related to special projects, complaints and lot qualification. Maintain accurate documentation and files related to special projects, complaints and lot qualification. Review and analyze lot documentation (DHR’s) to determine if there are any anomalies that may have related to reported product failures. Process feedback letters and communicate to product support managers for various reporting sites. Perform basic product review and failure analysis. Support investigation and review of potential adverse events. Escalate complex complaint issues as per department policies and guidelines. Performs other duties as required

Hiregy, PEO Benefits Specialist I (Tier II) 09/24 -04/25

Responsible for ongoing processing, maintenance, and support of client accounts. Provides excellent customer service to clients, employees, and field partners via calls, faxes, and emails. Process benefit enrollments for PEO product offerings for clients to ensure timely processing. Research and resolve basic product and service issues from field clients and their employees to maintain accurate and timely responses. Documents information in CRM to track issues. Researches and resolves monthly audits to correct billing inaccuracies. Obtains and maintains benefit documentation to ensure compliance with all applicable state and federal regulations and laws, including Paychex Section 125 plan. Maintains knowledge of changes pertaining to various product offerings, regulatory changes, policy changes, and industry developments to ensure compliance with departmental processes and company guidelines related to PEO. Researches and corrects errors from audit reports and carrier discrepancy files. Interacts with Health & Benefit carriers to resolve customer needs. Participates in special projects and training sessions as needed.

ECI-RX, Post Market Surveillance/Medical Device Reporting 04/22 – 10/22

Responsible for evaluating and processing complaints received by a client; Support complaint receiving and handling (documentation, coordination, investigation, resolution, and closeout); Provide support with a backlog of complaints; Check accuracy of complaint files at various points in the process; Coach individuals where errors/mistakes are made to correct them; Support with follow-up activities (e.g. additional information and product); Support complaint closure within Agile Complaint Management System (CMS); Assess complaint events/files for reportability per client’s process and regulations; Initiate Medical Device Reports (MDR) for FDA submissions; Complete MDR/vigilance reports per client process and regulations; Regularly report to various levels of ECI/client management on the progress of Complaints and MDR; Facilitate Team Meetings to provide direction and continuous project alignment.

L&T Technology, Post Market Surveillance/Medical Device Reporting Consultant 03/20 – 05/20

Reviewed all created complaint records using Trackwise to determine proper coding and reportability and expedited those that were reportable. Evaluated submitted Field Service records for completion and searched for missing information and documentation via SAP and Salesforce work orders. Reviewed each package to determine if the record is properly categorized and completed. Entered and followed up on the complaint through investigation closure. Provided documented feedback to assure future compliance.

Oxford Global Resources, Complaint File Evaluation/eMDR submission Consultant 12/19 – 03/20

Receive and process complaints escalated from internal and external customers related to products manufactured and or distributed and serviced by Aesculap in a manner consistent with all laws and regulations for medical devices. Evaluate and assess incoming complaints for adverse event reporting. Verifies decisions for “Vigilance report not required” determinations. Verifies comprehensive content of draft MDR reports prior to submission of Form 3500A to FDA for local and global affiliates, as necessary. Based on assessed risks, coordinates the escalation to Medical Reviewer(s) for decisions regarding the potential for serious injuries. Prepare and submit Medical Device Reports for submission to the FDA using eMDR (WebTrader and e-submitter) programs. Responds to FDA’s Request For Information (RFI) on any required MDRs. Conduct follow up investigation on potential medical events including contacting hospital personnel. Possess understanding of risk management concepts and is capable of assessing product risks. Identify critical product issues and escalate through the quality system for Field Action, Corrective and Preventive Action (CAPA), Supplier Corrective Action. Oversight of critical Post Market projects and routinely share project goals, status, requirements, and deliverables to management.

Validant Consulting, Complaint File Evaluation and Oversight Specialist Consultant 02/18 – 04/19

Reviewed all customer feedback and created complaint records via gCAPA and SmartSolve. Reviewed complaints for FDA reportability and expedited those that were reportable. Evaluated submitted Field Service records for completion and followed up with the Field Service Engineers for missing information and documentation. Reviewed each package to determine if the record is properly categorized and completed. Entered and followed up on the complaint through investigation closure. Provided documented feedback to the affected field service representative to assure future compliance. Administrative support to Project Lead; Team lead for Life Sciences product line.

HealthCare Support, Credentialing Consultant/Administrative Support Consultant 09/16–12/17

Verify insurance and coverage for patients PIP medical billing, supervised staff, maintain all logs required by AHCA; Verify medical staff credentials; Review certificates, state licenses, liability insurance, DEA license; Maintain database information via Salesforce, OmniFlow; Administrative support to Manager and Supervisor.

Cigna, New Business Assistant/Salesforce Administrator 12/14 – 05/16

Managed the Sales Intake Presale process and the RFP process: monitored the RFP Intake Mailbox, retrieving the RFP information, reviewing and analyzing RFP documents, ensuring critical data was entered into Salesforce.com timely, accurately and completely; Ensured accuracy of information and opportunities in Salesforce.com by monitoring inconsistencies, determining if similar leads were duplicates, editing data, correcting misspellings, adding records and deleting duplicate records; Identified any potential Decline-to-Quote (DTQ) red flags and communicated to all appropriately; Responsible for the daily operations of sales support services; proactively supported the New Business Managers throughout the Presale Process; shared updates, new procedures, trends via Sharepoint; Ensured quality/volume/accuracy metrics were met; Prepared medical, dental and vision rate quotes using company rating systems; reported results and met submission turnaround times; Timely submission of complete and accurate proposal data; proactive communication with internal and external customers; maintain positive relationship with matrix partners.

Office Team/Robert Half, Various Administrative positions 03/2013 – 12/2014

Medicare/Medicaid credentialing for physicians, nurse practitioners, and others; Preparation of medical, dental and vision rate quotes and claims using company rating systems; Benefits administration including Workers Compensation, FMLA, benefits open enrollment, and HRIS administration; Administrative duties for Managers and Directors to include travel arrangements, expense reporting, correspondence, calendar.

Validant Consulting, Post Market Surveillance/Medical Device Reporting Consultant 07/08 – 03/09, 07/12 – 03/13

Prepared and submitted FDA MedWatch and Baseline reports in strict adherence with regulatory requirements and timelines; Completed global complaint handling and adverse event reporting activities; Investigated product complaint events by communicating with departments as needed; updated SAP to analyze results/findings/trends; Partnered with Complaint Investigation Sites (CIS) to ensure thorough and timely investigation reports for returned product; Reviewed and analyzed investigation for completeness and detail; Ensured complaint records, MedWatch reports (FDA Form 3500A), and applicable complaint handling documents were compliant with Good Documentation Practices (GDP) and all FDA regulations and standards related to the review of events/complaints; Performed MDR searches/queries, conduct data analysis and develops reports for management review as required via SAP; Provided support for internal quality audits of complaint files / MDR documentation; Conducted follow-up investigation for reported MedWatch Reports and assisted in data collection and reporting for trending purposes; Maintained compliance with the site Quality System; Professional contact with customers to gain insight into each complaint event.

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