Rufie T. Roberts
Pittsburg,USA
Summary
Regulatory affairs specialist with expertise in complaint management and quality assessment. Demonstrated success in training and onboarding new hires, enhancing documentation practices, and ensuring compliance with regulatory standards. Committed to improving patient safety and fostering teamwork within the organization. Proven ability to build strong relationships with stakeholders while streamlining complaint handling processes.
Overview
1
1
Certification
27
27
years of professional experience
Work History
Sr. Specialist Regulatory Affairs
Abbott Diabetes Care
01.2018 - Current
- Executed timely review, documentation, and filing of Medical Device Reports to FDA (US), Medical Problem Reports to Health Canada, Medical Incident Reports to EU/EFTA including France, and Medical Device Incident reports globally for division's products.
- Review medical complaints and potentially reportable events for the purpose of researching and gathering additional information needed to determine MDR and/or Vigilance reportability.
- Interact with Customer Service, Complaint Evaluations Group and Complaint Investigations Group to gather appropriate information to determine whether a complaint requires an MDR and/or Vigilance report.
- Work with Complaint Investigation Group to gather the appropriate information from a returned device investigation for submission of an MDR/Vigilance follow up report.
- Filing of all medical events and reportable malfunctions within the required timeframe.
- Perform verification of MDRs/Vigilance reports, including data compiled for metrics, risk evaluations and various other MEG related activities.
- Developed compliant solutions for cross-functional teams to enhance accurate documentation of complaint cases and improve MEG processes.
- Maintained the Malfunction Reportability Assessment Matrix (MRAM) and updated the Reportable Confirmed Malfunction List (RCML).
- Demonstrates subject matter expertise, guidance, and training to other members of the Medical Events Group as well as to other functional departments.
- Conducted training sessions for new team members on complaint handling processes, enhancing team competency and compliance.
- On-board 18 new hires in assessing and processing Reports to the FDA (US-MDR), Medical Problem Reports to Health Canada (MPR), Medical Incident Reports to the EU/EFTA (MIR), and non-EU submission (MDI).
- Provide consultation or support to new team members regarding Reportability and proper documentation of reports.
- Trained on determining the reportability of incoming complaints as it relates to our product quality.
- Outlined the requirement of proper investigation writes-up, when to perform a customer service follow-up to obtain the needed information to properly assess the complaint.
- Continue to seek diversity of opinion within the team as it is important that everyone feels heard when joining an organization, or even once you have been established.
Quality System Complaint Specialist
Fresenius Medical Care
01.2004 - 01.2018
- Assess incoming information, data, and circumstances surrounding a reported complaint to determine the risk associated with the event and potential patient impact.
- Review and evaluate any written electronic or oral communication complaints in accordance with Good Manufacturing Practices (GMP).
- Ensure timely response and closure of complaint files.
- Maintain the quality, durability, reliability, safety, effectiveness, and performance of the company’s medical devices.
- Initiate return of defective parts to Investigations Department.
- Validated customer information by effectively communicating with field service reps.
- Develop and validate department procedure protocol.
- Developed guidelines that enhanced departmental efficiency.
- Ensured workplace safety and compliance by adhering to OSHA and FDA guidelines.
T&C / Final Hemo Test Technician
Fresenius Medical Care
01.2000 - 01.2004
- Independently tested, calibrated, repaired, and cleaned kidney dialysis machines while maintaining FDA and ISO guidelines.
- Utilized voltmeter, oscilloscope, gauges, scales, powered hand tools, and computer to accurately execute testing processes for kidney dialysis machines prior to customer shipping.
- Thoroughly prepared and tested kidney dialysis machines within the tolerable specifications prior to shipping to customers.
- Diagnosed and repaired failures in kidney dialysis machines, ensuring operational reliability.
- Assembled additional electrical and non-electrical components.
- Verified proper labeling and cleanliness of machines to comply with shipping standards.
Education
Master Degree - Regulatory Affaire
George Washington University
Washington, DC06-2018
Bachelor Degree - Criminal Justice Systems
California State University
East Bay03-2014
Associate Degree - Criminal Justice Systems
Los Medanos College
Pittsburg, CA01-2012
Associate Degree - Science Electronic Technology
Heald College School of Technology
01-2000
Skills
- Microsoft PowerPoint
- Team building
- Problem solving
- Microsoft Office
- Excel
- Medical device reporting
- Regulatory compliance
- Complaint handling
- Risk assessment
- Quality assurance
- Cross-functional collaboration
- Effective communication
- Training and development
- Attention to detail
- Management collaboration
- Team collaboration
- Documentation management
- Continuous improvement
- Quality assessment
- Time management abilities
- Multitasking Abilities
- Decision-making
- Professionalism
- Organizational skills
- Analytical thinking
- Coaching and mentoring
- Expert problem solving
- Troubleshooting techniques
Certification
- American Society for Quality (ASQ): FDA, Notified Body and Internal Auditing
- STAND! For Families Free of Violence: 40-Hours of Domestic Violence Counselor Training. California Evidence Code 1037.1
- CPR certified
Affiliations
- Give back to the community by volunteering through food banks, community theater, advocate for foster children through the courts, and work with women and children that have experienced violence.
Timeline
Sr. Specialist Regulatory Affairs
Abbott Diabetes Care
01.2018 - Current
Quality System Complaint Specialist
Fresenius Medical Care
01.2004 - 01.2018
T&C / Final Hemo Test Technician
Fresenius Medical Care
01.2000 - 01.2004
Master Degree - Regulatory Affaire
George Washington University
Bachelor Degree - Criminal Justice Systems
California State University
Associate Degree - Criminal Justice Systems
Los Medanos College
Associate Degree - Science Electronic Technology
Heald College School of Technology