Jennifer Dunham Email & Phone Number

Abbott Park, Illinois, Us

Director Regulatory Affairs for connected cardiovascular implantable electronic device systems with a focus on leadless and traditional pacemakers and insertable cardiac monitors.

Abbott Park, Illinois, Us

Associate Director Regulatory Affairs for cardiovascular implantable electronic devices and digital health systems.President's Award Recipient:• Fastest time to medical device CE marking• First-of-Its-Kind ICM2 device

Abbott Park, Illinois, Us

Sr. Regulatory Affairs Manager for cardiovascular implantable electronic devices and systems.

Abbott Park, Illinois, Us

Regulatory Affairs Manager for cardiovascular implantable electronic devices and systems.

Abbott Park, Illinois, Us

Regulatory Affairs Project Manager for cardiovascular implantable electronic devices and systems.

Abbott Park, Illinois, Us

Irvine, Ca, Us

• Served as product development team member to develop and execute global regulatory strategies for the US (PMA) and international/Europe markets for Class IIa and III endovascular devices• Supported Endologix’s use of OEM/OBL medical devices and medical device software, including collaboration and final review of OBL 510(k) filings• Provided regulatory assessment of changes to approved products, processes, and procedures; prepared, submitted, and responded to queries for PMA supplements and design dossier change notifications• Minimized the cost impact of DuPont’s Tyvek® process change by assessing the test data provided by DuPont and pouch suppliers, leveraging data to support Endologix’s pouch configuration and materials and determining the sample selection and packaging qualification testing required to minimize regulatory burden• Contributed to $200,000 annual savings in the implementation of electronic labeling, ensuring procedures and documentation were updated and executing the regulatory strategy and applicable regulatory filings• Achieved compliance with FDA’s Unique Device Identification (UDI) final rule by establishing internal processes and working with a cross-functional team, leading to early compliance with no errors in GUDID data• Developed and contributed to ongoing improvements to operating procedures

Irvine, Ca, Us

• Provided regulatory assessment of changes to approved products, author letters to file for inclusion in the PMA annual report, and prepared, submitted, and responded to queries for PMA/design dossier supplements in direct correspondence with FDA and the notified body• Ensured a continued state of compliance by managing recurring registrations and annual filings and preparing metrics on regulatory processes• Contributed to improvement of company’s customer and sales management, device tracking, and physician/sales force training programs by supporting the implementation and validation of Salesforce.com CRM software• Optimized the device tracking process using lean six sigma continuous improvement methodologies

Us

• Managed the customer complaints system and ensured 100% compliance rate in timely filing of MDRs and vigilance adverse event reports• Ensured effective and timely resolution of nonconformance reports and CAPAs• Maintained device technical files and supported international submissions• Prepared quality system analytics and developed and administered GMP training sessions• Ensured product quality by performing review and approval of device history records prior to product release and performed pre-shipment inspections• Successfully managed cross-functional process improvement projects to improve the final product cleaning process to mitigate product bioburden and to improve the calibration and maintenance program• Conducted (hosted), documented, and coordinated internal and third-party QMS audits• Initiated, reviewed, and approved change control documentation• Managed equipment calibration• Prepared FDA annual report for radiation-emitting products

Managed Document Control Department (5 direct reports), Quality Systems (change control, failure investigations, complaints, CAPA, etc.), and Training Program for an FDA-regulated drug manufacturer. Reviewed and trended quality, production, analytical, and environmental monitoring data for management review. Incoming material control & release. Calibration/maintenance program. Developed/administered GMP training sessions. Maintained drug master file. Project manager for Electronic Document Management System (EDMS) selection and implementation, bringing the company from paper-based to electronic QMS Records and processes. Performed DEA ARCOS reporting, controlled substance inventory tracking/shipment controls. Supported internal and external QMS audits.