[Skip to main content](#main-content) [OpenNash Jobs](https://jobs.opennash.com/) [Hiring report](/reports/hiring/) · [All Edwards Lifesciences jobs](https://jobs.opennash.com/companies/edwards-lifesciences/) · [Search jobs](/search/) Edwards Lifesciences · USA - California – Irvine # Senior Specialist, International Regulatory Affairs TMTT USA - California – Irvine Senior individual contributor $92,000 to $130,000 Legal & Compliance Listed on Edwards Lifesciences’s official careers site. Posted September 24, 2026. Check that it is still open and apply there. [Apply on Edwards Lifesciences’s careers site →](https://edwards.wd5.myworkdayjobs.com/EdwardsCareers/job/USA---California--Irvine/Senior-Specialist--International-Regulatory-Affairs-TMTT_Req-50966) [OpenNash Jobs](https://jobs.opennash.com/) / [Edwards Lifesciences](https://jobs.opennash.com/companies/edwards-lifesciences/) / Senior Specialist, International Regulatory Affairs TMTT ## Job description Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex domestic and international 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. Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. ### How you will make an impact - Create complex regulatory submissions (exercising judgment to protect proprietary information) for finalization and submission by OUS EW affiliates; track timelines and document milestone achievements, develop regulatory strategy, prioritize strategies/submissions with operating plans as well as ensuring alignment with KOD in countries (e.g., OUS, [the globe minus US, EU, Canada]) - Represent the OUS regulatory function on manufacturing and product development teams to provide 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 - Provide 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 - Provide 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 will need (Required): Bachelor's Degree & a minimum of 5 years related experience OR equivalent work experience based on Edwards criteria Coursework, seminars, and/or other formal government and/or trade association training Experience in preparing domestic & international product submissions What else we look for (Preferred): A Bachelor’s degree in a scientific discipline - Solid knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices - Solid knowledge and understanding of global regulatory requirements for new products or product changes Experience in preparing domestic & international product submissions - Solid knowledge of new product development systems - Solid knowledge of international regulatory requirements - Excellent problem-solving, organizational, analytical and critical thinking skills Strict attention to detail 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 $92,000 to $130,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. ## At a glance - Posted by the employer: Sep 24, 2026 - First seen by OpenNash: Oct 11, 2026 - Last checked: Oct 18, 2026 - Listed for: 24 days - Location: USA - California – Irvine - Pay: $92,000 to $130,000[Apply on Edwards Lifesciences’s careers site →](https://edwards.wd5.myworkdayjobs.com/EdwardsCareers/job/USA---California--Irvine/Senior-Specialist--International-Regulatory-Affairs-TMTT_Req-50966) ## More jobs at Edwards Lifesciences ### [Director, Regulatory Counsel](https://jobs.opennash.com/companies/edwards-lifesciences/jobs/37dc9d840b922032f2db/) USA - California – Irvine ### [Regulatory Affairs Specialist, Corporate Regulatory](https://jobs.opennash.com/companies/edwards-lifesciences/jobs/874fed61ae879662e7ed/) USA - California – Irvine ### [Senior Analyst, Quality Compliance](https://jobs.opennash.com/companies/edwards-lifesciences/jobs/af2861168afffd0d647c/) USA - California – Irvine ### [Analyst, Clinical Contracts and Budgets](https://jobs.opennash.com/companies/edwards-lifesciences/jobs/b10411ecdbce4d45b3f7/) USA - California – Irvine ### [Analyst, Data Analytics TMTT](https://jobs.opennash.com/companies/edwards-lifesciences/jobs/d1925ead09355c82feb9/) USA - California – Irvine ## Similar jobs at other companies ### [Principal Regulatory Affairs Specialist](https://jobs.opennash.com/companies/cardinal-health/jobs/33905438205fffb92ba7/) Cardinal Health · International ### [Staff International Regulatory Affairs Specialist](https://jobs.opennash.com/companies/stryker/jobs/acdf3524ef2b96efcc1e/) Stryker · Irvine, California ### [Global Regulatory Affairs Manager, Oncology](https://jobs.opennash.com/companies/gsk/jobs/09fdd8d7e12226e3ad65/) GSK · Rockville, Maryland, United States of America ### [Director, Global Regulatory Affairs (GRL)](https://jobs.opennash.com/companies/daiichi-sankyo/jobs/23bdbd6a298974011fee/) Daiichi Sankyo · Basking Ridge, NJ, USA ### [Director, Regulatory Affairs, Companion Diagnostics](https://jobs.opennash.com/companies/daiichi-sankyo/jobs/fdf9cbaa775b4385105d/) Daiichi Sankyo · Basking Ridge, NJ, USA OpenNash lists jobs from employers’ own careers sites and does not handle applications. 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