Jennifer Carr

Performed regulatory assessments for changes to drug delivery systems, including software, hardware, and labeling. Approved CAPA reportable events and provided NC oversight and approval.

Performed compliance assessments for on-market product issues generated through complaints or internal nonconformances. Implemented a structured process for identifying, assessing, and controlling potential hazards and risks associated with a medical device.

Developed Clinical Evaluation Plans (CEPs) and generated Clinical Evaluation Reports (CERs) for medical device manufacturer clients. Operated to ensure compliance with European Regulation EU MDR 2017/745 and maintained Product Safety Update Reports (PSURs).

Maintained and submitted Technical Documentation to notified body GMED and updated Clinical Evaluation Reports (CERs). Completed successful reclassification of devices and managed internal audit programs.

Provided SQE support for product acquisitions and managed CAPA resolution with suppliers. Monitored and reported nonconforming materials.

Managed and maintained QMS compliance as a leader for three sites and coordinated Corrective and Preventive Actions (CAPAs). Executed gap assessments for various QMS elements and implemented quality management integration activities.

Managed product remediation for consent decree with FDA and ensured regulatory documentation was compliant globally. Responded to inquiries by the FDA and competent global authorities.

Executed quality functions for permanent implantable devices and functioned as CAPA coordinator for multiple product lines. Drove and facilitated operational improvements on a divisional level.

Implemented and maintained new risk management process for post-market quality of whole blood analyzers. Reviewed and approved complaint reports and protocols to ensure objective analysis of products.

Studied Business Administration, focusing on foundational business principles and practices. Gained knowledge in management, marketing, and finance.

Focused on Business Information Technology Management, integrating business strategies with information technology solutions. Developed skills in IT project management and data analysis.