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Medical Device

Fort Worth, TX
October 11, 2018

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**** **** ****** ****** *** **6,

Fort worth texas 76120

682-***-**** .


Persistent, Organized and detailed oriented professional interested to pursue a position as an accomplished regulatory specialist with a pharmaceutical / biotechnology firm searching for opportunity to put my skills and past experience to work to help company reach both short and long-term, where I can utilize my strong medical and laboratory skills knowledge along with my strong technical and procedural skills to meet the growing needs for compliance to regulatory requirements.


● Highly experienced in complaint handling, reporting, trending and troubleshooting

● Experience with Class III medical devices.

● Wide knowledge of FDA regulations, safety standards and regulatory compliance guidelines

(ICH-GCP, Global FDA, FDA)

● Ensures in preparing, tracking, and managing regulatory submissions based on MDD and MDR requirements that support new product registrations.

● Maintains knowledge of required systems including CTMS and current TMF archiving system. Ensures these systems are updated as required.

● Ensure that the operations are at a state of inspection readiness and that applicable SOPs are adhered to and cGMP is practiced.

● in preparing, tracking, and managing regulatory submissions that support new product registrations

● Deeply Familiar with FDA 21 CFR 820.198, 2QSRs, ISO 9001 and other medical device regulations

● Superior organizational skills that help maintain data and appointments

● Effective team player with exceptional written, oral communication and interpersonal skills

● Focused and hardworking; able to troubleshoot complex problems and get the job done

● Performs all duties in compliance with FDA, OSHA and other regulatory requirements.

● Excellent written, oral communication and interpersonal skills

● Proficient with computer and Microsoft Office.

● Skilled at studying data and identifying the mistakes and loopholes within

● Assists with internal and external audit-related activities including preparation, defining CAPAs, and ensuring CAPA targets are met.

● Superior research and investigative skills that help perform root cause analysis

● A thorough professional with high regards to corporate ethics and mannerisms

● Proficient with use of computer and Microsoft word, Excel, PowerPoint, Outlook, Access, etc. PROFESSIONAL EXPERIENCE


Regulatory Compliance Specialist, Post Market Surveillance September 2017 - Present


1401 Mill Valley Square Apt 306,

Fort worth texas 76120

682-***-**** .

Abbott Laboratories

● Facilitating complaint communications and assess for regulatory reportability and potential impact to patient safety and business operations

● Completes and submits regulatory reports within the timeframes mandated by the FDA.

● Ensures complete and accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data or adverse reaction data as required by regulatory agencies

● Determine if investigation is necessary. If investigation is necessary, determine potential cause and contributing factors to the alleged event, device relationship, whether or not formal device investigation is necessary.

● Investigates complaints by gathering sufficient data from clinical staff, field representatives, internal employees, and laboratory analysis.

● Evaluates identified complaints, enter all information related to the events into complaint database, train others on proper method of reporting complaints Medical Device MDR and Vigilance Specialist

November 2014 - August 2017

Alcon Laboratories

● Ensures accuracy of data received from other internal databases by researching and following up when necessary (customer returns and service requests).

● Coordinate with team to determine if the reported complaint was associated with a malfunction, serious injury or death and whether the complaint documentation is complete and accurate

● Review and evaluate complaints for MDR reporting decisions in accordance with FDA guidance

● Responsible for conducting medical evaluations, information gather, communicate with medical professionals, end user, etc., for MDR determinations

● Reviews potential complaint data received via safety system(s), phone, fax, mail, or other methods

● Enters complaint data into designated safety database(s) using Good Documentation Practices


● Performs complaint follow-ups: missing and additional information, sample status and questionnaire status

● Performs integrity checks and file audits to ensure data consistency and identify missing data and/or attachments.

● Coordinates sample returns and ensures they are sent to the appropriate investigation sites.

● Closure of complaints (whether reportable or non-reportable cases) Complaint Coordinator, August 2012 – October 2014

Calvary Hill Health Services

● Assigned investigative tasks to analyze root cause and resolution of identified clients’ complaints.


1401 Mill Valley Square Apt 306,

Fort worth texas 76120

682-***-**** .

● Collaborating with Hospitals, Doctors’ offices, Medical suppliers and Pharmacy stores to complete complaint analysis and compile investigation results.

● Entering Clients complaints into customized data warehouse using Microsoft SQL data management tools.

● Analyzing complaint data monthly to identify new and systemic issues as necessary and collaborates with management for solutions.

● Preparing responses to customers and field as necessary per process

● Documenting all correspondences including but not limited to medical records, invoices and service requests upon receipt

Office Manager, December 2011 – July 2012

Dover Home Health

● Updated, filing, and maintaining all patient charts with Medicare and HIPAA compliance.

● Assembled charts before each new patient admission. Oversee and submit all Medicare, Medicaid, VA and other insurance billing claims.

● Assisted RN’s with ICD-9 Coding and sequencing and verifying the codes are correct. Typing and mailing all plans of care and physicians orders.

● Answered the phones and checking the office email. Calculating all mileage logs for RN’s, Home Health Aides, and Homemakers.

● Charged any RN, CHHA, PT, OT, or Speech therapy visits for all patients. Keeping monthly stats for patient load.

● Maintained inventory of medical supplies and charge sheets for those supplies. Inputting OASIS information into software and transmitting to CMS to report agency quality measures.

● Submitted, printed, and organized remittance advices for previous billing EDUCATION

● Babcock University, Nigeria - Bachelor of Science in Nursing 2011 (GPA: 3.71/ 4.0)

● Providence heights High School - Diploma, 2005


● Current CPR

● Current ACLS

● Capable in Itrack, Trackwise, Epic Microsoft Office Suite: Excel, Word, Power Point, Outlook, Access and SAP


Available upon request


1401 Mill Valley Square Apt 306,

Fort worth texas 76120

682-***-**** .

Contact this candidate