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

　　Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards' groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

　　Please note this is a high-engagement, office-based position at Edwards' site in Draper, Utah.

　　How you will make an impact:

　　Represent 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 recommends multiple solutions for selection by management. Prepare formal Regulatory Plans. Review and approve protocols, reports, engineering drawings, procedures, and other product development and manufacturing documentation to ensure regulatory requirements compliance, consistency, and accuracy.Prepare, provide direction and oversee documentation packages for submission to global regulatory agencies. Prepare GUIDID submission data. Track timelines and documents milestone achievements for inclusion in regulatory submissions. Interact with regulatory agencies as part of submission review and on-site audit support. (e.g., PMA's, annual reports, 510(k)'s, STED's and CE marking Technical Documentation and GSPR).Provide guidance on regulatory requirements necessary for strategic and contingency planning, including developing regulatory strategic plans and leading teams to implement solutions.Review labeling content, product and process changes, and product documentation to ensure regulatory requirements compliance, consistency, and accuracy.Monitor proposed and current global regulations and guidance; assess impact of such regulations and guidance on assigned project(s), propose suggestions on utilizing regulatory updates to expedite approval processOther incidental duties

　　What you'll need (Required):

　　Bachelor's Degree in a related field and 8 years of previous related experienceMaster's Degree in a related field and 6 years of previous related experienceCoursework, seminars, and/or other formal government and/or trade association training

　　What else we look for (Preferred):

　　Bachelor's or Master's degree in scientific discipline (e.g., Biology, Microbiology, Chemistry) or Engineering disciplineExperience in preparing domestic and international product submissionsExtensive knowledge and understanding of global regulations relevant to Class II and/or Class III medical devices, with focus on US and EU regulatory requirementsExtensive knowledge and understanding of global regulatory requirements for product changes.Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel Excellent written and verbal communication skills including negotiating and relationship management skills with ability to drive achievement of objectivesExcellent problem-solving, organizational, analytical and critical thinking skillsStrong leadership skills and ability to influence changeStrict attention to detailAbility to interact professionally with all organizational levelsAbility to manage competing priorities in a fast paced environmentAbility to work in a team environment, including inter-departmental teams and serve as key contact representing the organization on projectsAbility to interact with regulatory agencies and international regulatory partnersAdhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

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

　　COVID Vaccination Requirement

　　Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully 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 countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.