Brenda Driscoll has over 15 years of experience in medical device quality and regulatory compliance roles. She currently works as a senior post market compliance specialist for Insulet Corporation, where she is responsible for reviewing adverse event reports and ensuring timely submission to regulatory agencies. Prior to this, she held similar compliance roles at Smith & Nephew, Siemens Healthcare, Boston Scientific Corporation, and ConMed Endoscopic Technologies, where she gained extensive experience with complaint management systems and medical device reporting requirements.

1. BRENDA L DRISCOLL
10 B Spaulding Street
Townsend, MA 01679
978-726-7633
brenledjs@yahoo.com
TECHNICAL
SUMMARY:
• Accomplished medical device quality specialist working in fast-paced, detail oriented environments
demanding thorough organizational, interpersonal and computer proficient skills
EXPERIENCE:
2015-Present Insulet Corporation (Eliassen Consulting Services Contractor), Billerica, MA
Team Lead / Senior Post Market Compliance Specialist
• Complete review and approval for medical device and adverse event reports to FDA and International
Regulatory agencies within required timelines.
• Review, approve, edit and submit follow up adverse event reports as required.
• Responsible for determining if incidents meet the criteria for reportable events according to the FDA
and/or foreign government agencies guidelines.
• Provide regulatory compliance support for FDA remediation project.
• Train team on company procedures, processes and Electronic Complaint Management, SmartSolve,
and Pilgrim Software, including eMDR.
• Provide daily reports and team work assignments while aligning with company priorities.
2013 – 2015 Smith & Nephew Advanced Surgical Devices (Eliassen Consulting Services Contractor), Andover, MA
Regulatory Compliance Specialist
• Responsible for determining if incidents meet the criteria for reportable events according to the FDA
and/or foreign government agencies guidelines.
• Assess product incident reports and prepare and submit medical device and adverse event reports to
the FDA and International Notified Bodies as required.
• Provide regulatory compliance support to internal and international business partners.
• Possess knowledge of Quality System Regulation (QSR) and Good Manufacturing Practices (GMP).
• Manage documentation of decisions and communications, and handle the correspondence and
closure of the complaint files using Electronic Complaint Management, SmartSolve, and Pilgrim
Software.
• Complete risk management triage for each complaint, including severity ratings and depth of
investigation.
2012 – 2013 Siemens Healthcare (ICONMA Consulting Services Contractor), Walpole, MA
Quality Management Compliance Engineer
• Responsible for determining if incidents meet the criteria for reportable events according to the FDA
and/or foreign government agencies guidelines.
• Maintain knowledge of quality regulations in the United States, European Economic Area,
Switzerland, Canada and Australia.
• Responsible for writing Medical Device Reports using eSubmitter according to FDA guidelines and
submission of these reports in a timely manner.
• Provide Medical Device Vigilance Reports to the European Union Authorized Representative.
• Manage documentation of decisions and communications, and handle the correspondence and
closure of the complaint files using Electronic Complaint Management System CCHS, Documentum
and Live Link following Federal Food and Drug Administration’s Good Manufacturing Practice and
Medical Device Reporting regulations and company Standards of Operations.
• Process and edit engineering change orders for Standard of Operations documents using SAP.
• Maintain knowledge on over 75 reagents for in vitro diagnostics (IVD) and practices by reading
product instruction for use documents.

2. BRENDA L DRISCOLL
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2007 – 2011 Boston Scientific Corporation, Marlboro, MA
Post Market Surveillance Product Analyst II
• Trainer for TrackWise Complaint Handling Database System including eMDR.
• Manage product complaint activities for the Endosurgery Complaint Management Center (CMC) using
TrackWise Complaint Management System, following Federal Food and Drug Administration’s Good
Manufacturing Practice and Medical Device Reporting regulations.
• Manage documentation of decisions and communications, and handle the correspondence and
closure of the complaint files.
• Responsible for determining if incidents meet the criteria for reportable events according to the FDA
guidelines and submission of these reports in a timely manner.
• Manage field service records for urological and gynecological product lines and disposition each as
required.
2006 – 2007 ConMed Endoscopic Technologies, Billerica, MA
Field Assurance Coordinator/Compliance Specialist
• Administrator and trainer for TrackWise Complaint Handling Database System.
• Collect all data points from CET Sales Representatives, physicians and medical personnel required
by the Federal Food and Drug Administration’s Good Manufacturing Practice and Medical Device
Reporting regulations.
• Manage documentation of decisions and communications, forwarding complaint devices for
evaluation and for handling the correspondence and closure of the complaint files.
• Responsible for determining if incidents meet the criteria for reportable events according to the FDA
and/or foreign government agencies guidelines and submission of these reports in a timely manner as
dictated by each agency.
• Conduct and document internal trend analysis to identify device or process improvements and
reduction in complaint/MDR reporting.
• Maintain knowledge on ten gastroenterology product lines encompassing over 500 product end items,
endoscopic procedures and practices by reading product brochures, manuals, periodicals and
attending product training sessions.
• Maintain knowledge of quality regulations in the United States, European Economic Area,
Switzerland, Canada and Australia.
2004 – 2006 ConMed Endoscopic Technologies (formerly C.R.Bard), Billerica, MA
Executive Administrator/Executive Secretary
• Trainer for Qumas e-Doc Compliance electronic document management system (Billerica, El Paso,
and Juarez).
• Responsible for Medical Device Reporting and complaint handling using TrackWise Complaint
Management System.
• Perform product decontamination on returned medical devices.
• Administrator and trainer for TrackWise Complaint Handling Database System.
• Manage and update Divisional Corrective and Preventative Action Document Management System.
• Administrator for TrackWise CAPA System.
• Manage and organize divisional product recall projects meeting FDA compliance requirements.
OTHER EXPERIENCE:
1979 U.S. Air Force
• Honorable Discharge
• Aircraft electrician with Secret Clearance
• Member of the Edwards AFB Honor Guard
EDUCATION:
1995 University of Massachusetts, Lowell, MA
• Bachelor of Arts
• Magna cum Laude, GPA 3.9
TRAINING:
2005 – 2007 TrackWise Complaint Handling Database System
• Train the Trainer
2005 QUMAS Enterprise Compliance Management
• Train the Trainer