Global Regulatory Affairs Strategist for Patient Impact

Support the safety and efficacy of our technology

Our Regulatory Affairs team works at the forefront of medical innovation, helping ensure our technology meets the highest standards possible of safety and efficacy. You’ll be part of a collaborative, purpose‑driven environment that values expertise, open dialogue, and shared accountability. You'll also join a team invested in your growth through continuous learning, expanded exposure to new technologies and markets, and opportunities to deepen your strategic influence as you help turn innovation into meaningful patient impact.

Your dedication to our meaningful work will help enable patients to live longer, healthier lives.

Help us make thoughtful and strategic decisions that directly influence product development, global market access, and patient outcomes. With us, you’ll belong to a team whose number one priority is transforming patient lives.

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We're seeking professionals who are eager to work on early design and development through global market approvals and post market changes. Come partner with R&D, Clinical, Manufacturing, and Quality to bring complex medical technologies to patients worldwide.

Strategy - High-level planning and decision-making to align regulatory pathways with business objectives.

• Define and execute global regulatory strategies aligned with business objectives
• Influence development timelines, market entry plans, and risk mitigation approaches
• Advise on device classification, clinical requirements, and regulatory pathways
• Engage with regulatory authorities and support high‑impact interactions

Operations - Execution and management of regulatory processes

• Lead and support preparation of global submissions and regulatory documentation
• Maintain technical files and submission tracking across regions
• Coordinate responses to regulatory authority questions and requests
• Support lifecycle management through compliant change assessments and documentation

We are seeking experienced Regulatory Affairs professionals who thrive in complex environments and are motivated by meaningful work. Our opportunities span multiple areas of the business and product lifecycle, from early innovation through sustaining and post‑market activities. Learn more about the skills and expertise we look for.

• Act as a strategic partner influencing timelines, market-entry plans, and competitive positioning, and product approvals
• Advise on device classification, clinical trial requirements, and risk mitigation
• Anticipate regulatory challenges and integrate compliance

Operations

• Track submission status and coordinate responses to regulatory authority queries
• Support compliance by managing technical files and archiving regulatory documentation

* Requirements may vary depending on the role.

Together, we navigate evolving regulatory landscapes to maintain our leadership in delivering safe, effective medical technologies to patients worldwide.

You will work alongside R&D, Clinical, Quality, Manufacturing, and Commercial teams, ensuring regulatory considerations are integrated early and effectively. Your work will support technologies that improve and extend lives, while upholding the highest standards of safety and effectiveness possible.

Our work is made possible by people around the world who are motivated by our vision and commitment to patients. Hear from a few of our inspiring team members.

Being part of Regulatory Affairs gives me tremendous opportunity to interact closely with every functional group. Each day we work together towards our vision of leading and transforming the treatment of patients.

In the dynamic and ever‑evolving regulatory environments, I've encountered numerous challenges. Yet, the unwavering support from management and the effective collaborations with stakeholders have been instrumental in navigating these complexities and turning them into opportunities.

I started working at Edwards at an entry‑level role and have spent more than ten years on a path marked by growth, perseverance, and purpose. What makes this work so meaningful is knowing that every regulatory milestone brings us one step closer to helping patients.

What I appreciate most at Edwards is the balance between creativity and structure that allows us to turn bold ideas into meaningful impact for patients. Working closely with teams across the organization and contributing to strong governance makes each day purposeful. I feel supported, challenged, and genuinely proud of the difference we make.

We’reseeking talented people to help usmake a meaningful difference inpatients’ lives.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.