Jobs at Edwards Lifesciences

Sustains and improves the Application Lifecycle Management platform in a regulated medical device environment. Partners with quality, engineering, validation, IT, manufacturing, and vendor stakeholders to gather requirements, define workflows, manage enhancements, support testing and validation, maintain traceability and documentation, troubleshoot issues, facilitate governance, and drive user adoption through training and communication.

Coordinates regulatory submission deliverables, documentation packages, records, databases, and tracking tools for global medical device regulatory activities. Supports process improvements, compliance assessments, audits, inspections, and regulatory documentation maintenance. Collaborates with regulatory affairs teams and cross-functional stakeholders while ensuring accuracy, data integrity, and adherence to global requirements for medical devices.

Leads commercial strategy and sales operations for a medical device business, translating executive priorities into action plans, governance, metrics, and cross-functional initiatives. Supports executive decision-making through briefings, business reviews, analytics, and performance reporting. Owns leadership team governance, operating cadences, strategic planning, risk mitigation, and organizational effectiveness. Partners with commercial operations, analytics, and business intelligence teams to improve execution and business performance.

Conduct field monitoring for clinical trials involving transcatheter heart valve devices. Verify trial data, source documentation, regulatory records, protocol compliance, safety, and investigational device accountability. Provide oversight and insights to investigators, sponsors, and ethics committees; recommend process improvements; and deliver training on GCP, protocols, compliance, adverse event reporting, and regulatory requirements. Travel domestically up to 75%.