Senior Manager Regulatory Affairs

Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Senior Manager, Regulatory Intelligence & Corporate Regulatory Affairs position is a unique career opportunity that could be your next step towards an exciting future. The Senior Manager, Regulatory Intelligence & Corporate Regulatory Affairs role will serve as a senior-level individual contributor and subject matter expert representing Edwards Lifesciences’ Corporate Regulatory Affairs function. This role provides strategic regulatory leadership on worldwide regulatory changes, translates complex requirements into actionable business strategies, and independently leads high-impact, cross‑functional initiatives that support global compliance and timely patient access to life‑saving products and therapies. The position exercises considerable judgment and influence across business units, regions, and functional areas to anticipate regulatory challenges, mitigate risk, and deliver sustainable enterprise solutions. How you will make an impact: Serve as a recognized subject matter expert on global regulatory intelligence, regulatory change management, and related corporate regulatory processes. Identify systemic risks, process gaps, and opportunities for improvement; develop innovative solutions; and independently lead multiple complex, enterprise-level regulatory initiatives and process‑improvement programs across business units, regions, and functional areas, with accountability for scope, strategy, risk, timelines, deliverables, and sustainable outcomes. Anticipate and interpret emerging global regulations, guidance, and standards; contribute to cross‑functional assessments of potential impact to products, processes, and quality systems; and recommend risk‑based strategies, priorities, and implementation approaches. Provide strategic direction for the Regulatory Intelligence process to enable early identification, communication, assessment, and implementation of regulatory changes that may affect Edwards globally. Translate complex or ambiguous regulatory requirements into practical business actions, compliance plans, decision frameworks, and contingency strategies that support timely market access and continuity of supply. Influence and align senior stakeholders across Business Unit Regulatory Affairs, Corporate Quality, global functions, and international affiliates to resolve complex issues, establish priorities, and drive timely execution. Lead complex stakeholder meetings and working sessions with cross‑functional and international partners, ensuring clear decisions, ownership, escalation, and follow‑through. Represent Corporate Regulatory Affairs on key cross‑functional initiatives and governance forums (e.g., global labeling initiatives) by presenting regulatory options, risks, tradeoffs, and recommendations to support informed decision‑making. Own and maintain regulatory operational activities, as assigned, including FDA device listings, establishment registrations, and State of California manufacturing license renewals. Lead regulatory change‑control activities for the Regulatory Suite and provide expert support to Edwards’ Standards Management Process. Provide technical leadership, coaching, and knowledge transfer to colleagues and project teams without direct people‑management responsibility. Operate with a high degree of independence, determining methods and approaches for new assignments and escalating material regulatory, compliance, or business risks as appropriate. Whatyou’llneed(Required): Bachelor’s degree with at least ten (10) years of regulatory affairs, regulatory compliance, or quality experience; or Master’s degree with at least eight (8) years of regulatory affairs, regulatory compliance, or quality experience; or equivalent work experience based on Edwards criteria. Demonstrated experience independently leading complex, cross‑functional regulatory initiatives in a highly regulated industry. Experience interpreting global regulatory requirements and translating them into risk‑based strategies, impact assessments, and implementation plans. Experience with regulatory submissions, regulatory systems, data, and digital tools. Demonstrated ability to influence decisions and drive alignment across organizational levels without direct authority. What else we look for(Preferred): Degree in a scientific, engineering, or related technical discipline. Medical device, pharmaceutical, or biotechnology industry experience. Advanced knowledge of global medical device regulations, including requirements applicable to Class II and/or Class III devices. Advanced knowledge of global regulatory requirements for new products, product changes, and quality‑system processes. Experience leading enterprise‑wide regulatory change‑management or compliance implementation programs involving multiple stakeholders and business functions. Demonstrated experience facilitating regulatory strategy discussions, driving alignment among stakeholders, and presenting recommendations to senior leadership. Experience assessing and implementing requirements associated with EU MDR and other evolving global medical device regulations. Experience supporting industry standards management programs and evaluating the impact of new or revised consensus standards on product development, manufacturing, and quality systems. Knowledge of ISO 13485:2016 and related training, certification, coursework, seminars, or government and trade‑association programs. Demonstrated ability to solve unique and complex problems with broad business impact and to develop innovative, sustainable solutions. Strong executive communication, facilitation, negotiation, and stakeholder‑influence skills in a global, matrixed environment. Strong judgment, strategic thinking, organizational, analytical, and critical‑thinking skills, with the ability to manage competing priorities. Proficiency with Microsoft Office applications, including Word, PowerPoint, and Excel. Aligning our overall business objectives with performance, we offer competitive salaries, performance‑based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California, the base pay range for this position is $145,000 - $205,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). #J-18808-Ljbffr