• Design, manage, and execute the Compliance Assurance Plan. • Drive the evolution of our Compliance Independent Testing Team (CITT) through automation, data-driven monitoring, and modern control-testing practices. • Lead and develop a high‑performing team of Compliance Testers across United States and Costa Rica, responsible for conducting independent reviews, control testing, validation, and monitoring activities. • Provide coaching, mentorship, and performance management to ensure technical rigor, consistency, and professional growth. • Partner with Compliance SMEs, Legal, Technology, Product, and Operational leaders to ensure alignment between testing activities and business risks. • Oversee the Compliance Annual Testing Calendar.

• lead and participate in global regulatory activities • develop innovative global regulatory strategies • provide strategic regulatory guidance for global development • coordinate with internal and external stakeholders • mentor junior staff • oversee regulatory activities and submissions • ensure compliance with global regulatory requirements

• Provide daily operational and compliance support for import and export processes of traded goods within a specific country or region • Administer free-trade agreement programs, including regular reviews of entry documentation and maintenance of tariff codes and country-of-origin (COO) data • Maintain internal controls and procedures to ensure compliance with trade regulations and minimize the risk of penalties or fines • Maintain organized and accurate trade records, update internal databases, and ensure activities align with established corporate policies, departmental procedures, and regulatory requirements • Serve as subject matter expert (SME) for general trade compliance and customs relations, including tariffs and VAT, training and educating cross-functional stakeholders throughout the organization • Interpret and apply trade regulations from various global agencies such as U.S. Customs and Border Protection (CBP) and World Trade Organization (WTO) • Assist with trade compliance projects relating to cost-avoidance programmes, duty drawback, free-trade agreements, and preferential origin • Complete or assist in applications of supporting documentation for export, import, shipping, and receiving processes to ensure accuracy and compliance with trade laws and country regulations • Stay updated on changes in international trade laws and regulations and communicate relevant updates to the appropriate stakeholders within the organization • Liaise with customs officials to facilitate the clearance of shipments, including handling of import/export documentation and potential issue resolution during the clearance process • Provide regular updates and reporting on key data and metrics to functional leadership; alert management to discrepancies and trends • Perform other duties as required, or assigned by management, to meet business needs • Adhere to company Personal Protection Equipment (PPE) policy

Role Description Enjoy the flexibility of working remotely—this position is 100% remote within the U.S. Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology. - Evaluate global complaint information provided, conduct additional investigation as needed and escalate as appropriate. - Evaluate complaints for Medical Device Reporting (MDR). - Prepare and submit MDR reports to FDA. - Process complaint files from initiation to closure. - Fulfill FDA, ISO and other relevant requirements for designated complaint handling unit, and evaluation of events for reportability to applicable regulatory bodies. How you will make an impact: - Assess complaint information provided and conduct additional investigation as needed and escalate as appropriate. - Seek information and input, and challenge as appropriate, from Product Safety, Engineering and other departments/business units for complaint investigations. - Evaluate complaints for Medical Device Reporting (MDR). - Prepare and submit MDR reports to FDA. - Identify problems and lead projects to improve processes, procedures, and/or practices; recommend and resolve solutions, including devising new approaches to problems encountered. - Summarize findings, including a review of the investigation, product analysis, imaging review, instructions for use (IFU), and any other relevant labeling and/or training materials, and formulate conclusions. - Evaluate event to determine if it qualifies as a complaint. - Manage customer relationship and expectations during course of complaint investigation and resolution process. - Prepare and submit final customer correspondence. - Lead and plan agenda for and run weekly meetings to discuss complaint issues with affected functions (e.g., Manufacturing, Quality Assurance, Suppliers, etc.) to identify assignable root cause, resolve open action items, and gather additional technical information to resolve complaint. - Analyze and/or audit complaint data/files and may develop reports. - Lead the investigation of complaints that include all complex scenarios. - Other duties assigned by Leadership (Attend cross-functional meetings to represent Quality Compliance and present open items for which resolution is needed). Qualifications - Bachelor's degree plus five (5) years of experience with complaint handling and evaluating complaints for MDR (Medical Device Reporting); or equivalent work experience based on Edwards criteria. - Medical Device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment/industry experience. Requirements - Experience submitting Medical Device Reports. - Proficient knowledge of medical terms and human anatomy. - Good knowledge of Good Documentation Practices (GDP) as it relates to complaint filing. - Strong knowledge and familiarity with 21 CFR 820 & 803 regulations. - Proven expertise in MS Office Suite and ability to operate general office machinery. - Excellent written and verbal communication skills and interpersonal relationship skills including consultative and relationship management skills. - Demonstrated problem-solving, critical thinking, and investigative skills working relationships. - Substantial knowledge and understanding of Edwards policies, procedures, and guidelines relevant to quality compliance. - Ability to manage confidential information with discretion. Benefits - Competitive salaries. - Performance-based incentives. - A wide variety of benefits programs to address the diverse individual needs of our employees and their families. Company Description Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement: Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.