• 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.

Role Description We’re looking for a Global Commercial Lead, ALS & Rett on the Commercial Management – Gene Therapy team to help us expand what’s possible for patients with serious disease. Report to the Global Commercial Head, Neuro & Other Rare, you’ll be responsible for leading the successful global commercialization of Amyotrophic Lateral Sclerosis (ALS) and Rett gene therapies. In this role, you'll have the opportunity to: - Develop, implement and evolve global commercial strategy, including market shaping, patient finding, and branded & unbranded campaigns, for our neuro gene therapies portfolio, with strong emphasis on US. - Create and maintain a ‘best in class’ Target Product Profile (TPP), in alignment with GPT, and therapeutic area leadership team. - Ensure commercial insights are integrated into clinical development, trial design and manufacturing scalability. - Partner with: - Field Leadership to achieve high-quality customer engagement, and treatment center support from treatment consideration to gene therapy administration. - Market Access and HE&OR to shape value proposition and architect innovative access models, reflecting the high unmet need and value of our gene therapies. - Patient Services, and Channel & Distribution to deliver an industry-leading patient and caregiver experience. - Patient Advocacy and Medical Affairs on external engagement strategy, conference planning, and KOL & PAG engagements for ALS and other neuro disorders. - Collaborate with commercial effectiveness to proactively monitor the competitive landscape, identify customer insights & analytics needs, and build revenue forecasts. - Champion commercial priorities in GPT, therapeutic area leadership, and with cross-functional colleagues. - Build and lead a high performing marketing team, fostering patient centricity, accountability, innovation, and operational excellence. Qualifications - Bachelor’s degree in business, marketing, science, or related field (MBA or advanced degree preferred). - 12+ years in biopharma marketing, including global commercial launch leadership in gene or cell therapy. - Experience with and deep understanding of one-time/specialized in vivo or ex vivo therapies administered in treatment centers (e.g., gene therapies, gene editing, cell therapies). - Proven leadership skills, and ability to select, develop, and mentor a high-performing team. - Strong analytical mindset related to market assessment, competitive intelligence, and HTA/pricing. - Ability to translate science into compelling customer value proposition and strategic narrative. - Ability to identify business opportunities and develop a research plan that will provide actionable insights. - Excellent written and verbal/presentation skills and proficient in Powerpoint, Excel, Word, SharePoint. - Ability to work in ambiguous environments and influence without authority. - Excellent collaboration and partner engagement skills, with capability to work across scientific and commercial teams. Requirements - Experience in neurology/neuromuscular diseases is a plus. Benefits - Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP). - Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration. - 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance. - Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities. - Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back. Company Description At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK. For patients, for each other, and for the future of science, we’re in. Are you?

• Lead SOX impact assessments for new products, non-routine transactions, and major business, system, or organizational changes that affect business process controls and ICFR posture. • Lead SOX evaluation for acquisitions and post-close integration, including designing control environments for acquired entities that may not have an existing SOX program. • Own the business process SOX control framework, including standards, methodology, and control design principles that can scale with company growth. • Identify control gaps, prioritize remediation efforts, and drive cross-functional action plans through resolution. • Partner closely with IT SOX leaders on integrated business and IT control design for system implementations and enterprise changes. • Lead coordination with internal and external auditors on business process SOX planning, walkthroughs, testing, audit requests, and deficiency evaluation. • Monitor changes in regulatory and accounting guidance and translate them into updates to controls, scoping decisions, and compliance practices. • Build, lead, and develop the Business SOX Compliance team, including hiring, coaching, reviewing work, and setting priorities aligned to the SOX strategy and risk assessment.