Sr. Specialist, International Regulatory Affairs, Critical Care

Make a meaningful difference to patients around the world. From design to production, our International Regulatory Affairs teams help guide our innovative technologies through complex international regulatory environments. Working in partnership with Edwards international regulatory partners, and alongside diverse internal stakeholders, your close attention to detail and technical mastery will help ensure our products reach clinicians and improve patients’ lives.

Throughout our history, Edwards has helped transform the way physicians monitor and take preventative measures for cardio patients. Our Critical Care business unit specializes in advanced hemodynamic monitoring solutions, including artificial intelligence algorithms to provide predictive readings to clinicians, helping them get patients home to their families faster. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

For decades, Critical Care has operated at the intersection of groundbreaking medical innovation and improved patient care. Put simply, we exist because we’re committed to creating a world where every patient who should be monitored will be monitored with smart technology.

With this impactful vision in mind, we are now embarking on becoming an entirely independent business from Edwards Lifesciences (NYSE: EW), a process that is on track to be completed by January 2025.

As Critical Care transitions to NewCo, we will continue to benefit from the expertise and experience of 4,000+ dedicated global employees, a vibrant innovation engine with 11% revenue re-invested in R&D, and strong sales growth and profitability. We will be well-positioned to pursue our focused strategy and build upon our category leadership in three important ways:

• Accelerating the shift from classic monitoring solutions to smart monitoring technologies

• Launching new, AI-enabled connected platforms to support our portfolio of products and

• Expanding into additional care settings with new, non-invasive monitoring technologies

So, if you're a dynamic and passionate person, eager to contribute to a leading advanced monitoring company, we invite you to explore our career opportunities. Those who choose to join us will be part of a ‘once-in-a-generation’ journey to improve the quality of care and outcomes for millions of patients around the world.

As a Senior Specialist, International Regulatory Affairs, you complete and maintain regulatory approvals and clearances of assigned products.

How you will make an impact:

• Creating complex regulatory submissions (exercising judgment to protect proprietary information) for finalization and submission by OUS EW affiliates; tracking timelines and documenting milestone achievements, developing regulatory strategy, prioritizing strategies/submissions with operating plans as well as ensuring alignment with KOD in countries

• Representing the OUS regulatory function on manufacturing and product development teams to providing input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving conflicts between those requirements and development issues, and/or reporting to management

• Providing guidance on strategies and contingency planning with respect to OUS regulatory requirements, including assessing impact of proposed and current global regulations and proposing suggestions for expediting approvals

• Providing guidance and feedback to business unit regulatory teams on registration requirements for new and renewal registrations, product and process changes, and review of labeling content and guidance on process improvement projects, based on prior experience and responses from affiliates

What you’ll need (Required):

• 3 years of previous related experience and Masters degree in related field OR

• 5 years of previous related experience and Bachelor's degree in related field

In addition to meeting the minimum qualifications above, we strongly prefer candidates who possess these critical skills and background helping us achieve our goals: 

• Experience with strong input/authoring 510(k)s

• Regulatory affairs experience with software devices and product development

What else we look for (Preferred):

• Experience preparing domestic and international product submissions

• Bachelors and/or Masters degree in scientific discipline

• Full knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices

• Full knowledge and understanding of global regulatory requirements for new products or product changes