Manager, 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 Manager, Regulatory Affairs, you are responsible for completing and maintaining regulatory approvals and clearances of assigned products.

How you will make an impact:

• Representing the regulatory function on manufacturing and product development teams as a subject matter expert (SME) to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving conflicts between those requirements and development issues; also recommending multiple solutions for selection by management. Preparing formal Regulatory Plans. Reviewing and approving protocols, reports, engineering drawings, procedures, and other product development and manufacturing documentation to ensure regulatory requirements compliance, consistency, and accuracy.

• Preparing, providing direction and overseeing documentation packages for submission to global regulatory agencies. Preparing GUIDID submission data. Tracking timelines and documenting milestone achievements for inclusion in regulatory submissions. Interacting with regulatory agencies as part of submission review and on-site audit support. (e.g., IDE’s, PMA’s, annual reports, 510(k)’s, STED’s and CE marking design dossiers and technical files).

• Providing guidance on regulatory requirements necessary for strategic and contingency planning, including developing regulatory strategic plans and leading teams to implement solutions.

• Reviewing promotional material, labeling content, product and process changes, and product documentation to ensure regulatory requirements compliance, consistency, and accuracy.

• Monitoring proposed and current global regulations and guidance; assessing impact of such regulations and guidance on assigned project(s), proposing suggestions on utilizing regulatory updates to expedite approval process

• Monitoring proposed and current global regulations and guidance; assessing impact of such regulations and guidance on multiple projects, proposing suggestions and leading the implementation on utilizing regulatory updates to expedite approval process.

What you’ll need (Required):

• Master’s degree and 6 years of previous related experience OR Bachelor’s degree and 8 years of previous related experience

• Coursework, seminars and/or other formal government and/or trade association training