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BDSenior Manager, Medical Affairs
Oct. 2019
GE Healthcare SurgeryProduct Surveillance Director
Aug. 2011 - Oct. 2019Salt Lake City, UTLead a Product Surveillance organization in meeting global regulations in the areas of post-market complaint handling, adverse event reporting, recalls, trending, and CAPA for a diverse and global portfolio of fluoroscopic X-Ray devices and accessories in a highly regulated consent-decree environment. • Oversee and monitor overall complaint handling and recall processes to ensure compliance with internal performance metrics and regulatory requirements. • Motivate a team of individual contributors and managers through inspiration, personal connection, example and accountability. • Drive product safety and quality improvements by providing valuable post-market insight to design teams engaged in new product introductions and risk management activities. • Communicate key performance indicators, metrics and product performance data to executive management and other key stakeholders. • Analyze changes to the regulatory landscape and define implementation strategies for continued compliance. • Directly interact with auditors and global regulatory agencies as subject matter expert during inspections, investigations, recall execution and other regulator inquiries. • Oversee Corrective and Preventive Action Actions related to customer complaints and product-related nonconformances. • Train, advise and coach business leaders on regulations, procedures and work instructions. • Develop strategy for responses to regulatory inquiries and audit nonconformances. • Lead cross-team process improvements, resulting in simple, sustainable and compliant processes.
GE Healthcare ITPostmarket Surveillance Manager
Jan. 2008 - Aug. 2011Barrington, ILManaged a Product Surveillance team supporting a complex portfolio of electronic health record products. • Managed overall complaint handling operations and associated processes. • Supported internal/external audits and led Corrective and Preventive Actions for nonconformances. • Identified and executed process improvements to improve complaint processing timeliness. • Reported key metrics and performance indictors to leadership. • Implemented electronic complaint handling system. • Developed complaint trending methodology and associated tools / processes. • Trained Product Surveillance professionals on related regulations, internal processes and tools. • Managed individual performance including objective setting, coaching and development of staff.
GE HealthcareCustomer Operations Manager
Aug. 2004 - Jan. 2008Responsible for building and maintaining relationships with several key, strategic accounts and managing all post-install service issues/escalations. Collaborated with leadership at all levels of the organization to drive escalated issues to closure and provide world class service to customers.
GE HealthcareSupport Services Lead
Apr. 2003 - Aug. 2004Managed and led the day to day operations of a 20 person technical and application support team.
GE HealthcareApplications Support Specialist
Sep. 2001 - Apr. 2003Provided technical and application/configuration support to 1,300 customers. Trained end users on application usage and configuration. Performed clinical application configuration as needed, based on individual hospital workflow needs/requirements. Diagnosed, researched and resolved software problems. Worked with other internal groups as needed to resolve more complex issues. Created application documentation for end users and other support team members. Trained other team members on supported products.
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