Full-Time
Senior Specialist
Regulatory Affairs THV
Posted on 8/12/2025
Edwards Lifesciences
10,001+ employees
Develops transcatheter heart valves and devices
Compensation Overview
$90k - $127k/yr
Irvine, CA, USA
In Person
 Legal & Compliance (2) |
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- Bachelor's Degree
- A minimum of 5 years of previous related experience
- Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving moderately complex conflicts between those requirements and development issues; also keeps management apprised of alternative actions.
- Review and approve protocols, reports, engineering drawings, procedures, and other product development and manufacturing documentation to ensure regulatory requirements compliance, consistency, and accuracy
- Provide guidance on regulatory requirements necessary for strategic and contingency planning, including developing the preliminary regulatory strategic plans
- Prepare and oversee documentation packages for submission to global regulatory agencies. Assist with GUDID submissions. Track timelines and documents milestone achievements for inclusion in regulatory submissions. May interact 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)
- 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 process
- Review labeling content product and process changes, and product documentation to assure regulatory requirements compliance, consistency, and accuracy
- Experience in preparing domestic and international product submissions
- Excellent written and verbal communication skills including negotiating and relationship management skills
- Excellent problem-solving, organizational, analytical and critical thinking skills
- 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 (US, EU, and Health Canada) for new products or product changes
- Full knowledge of new product development systems
Edwards Lifesciences focuses on cardiovascular medical technologies, especially transcatheter heart valves. Its products enable repairing or replacing diseased heart valves through minimally invasive procedures rather than open-heart surgery. The company builds on a long history that began with the Starr-Edwards valve and now centers on valve therapies and related diagnostics to treat heart disease. It differentiates itself by specializing in valve technologies and transcatheter approaches, backed by a track record of clinical leadership and global reach. The goal is to improve patient outcomes by providing safer, less invasive valve treatment options for people around the world.
Company Size
10,001+
Company Stage
IPO
Headquarters
Irvine, California
Founded
1958
Simplify's Take
What believers are saying
- Q1 2026 sales hit $1.65B, up 12.7% constant currency, raising 2026 guidance to 9-11% growth.
- Transcatheter Mitral and Tricuspid Therapies grew over 50% YoY to $173M in Q1 2026.
- Philips EchoNavigator R5.0 FDA clearance on March 27, 2026, enhances Pascal Ace procedures.
What critics are saying
- Abbott MitraClip erodes Pascal Ace share with 60-80% dominance in 12-24 months.
- Medtronic Evolut FX captures 10-15% Sapien TAVR revenue in 6-12 months.
- New CFO Mistras disrupts strategy, causing investor sell-off in 3-6 months.
What makes Edwards Lifesciences unique
- Pioneered Starr-Edwards mitral valve in 1960, first commercially available artificial heart valve.
- Global leader in transcatheter aortic valve replacement with Sapien franchise generating $1.2B Q1 2026.
- Shifted to pure-play structural heart focus post-$4.2B Critical Care sale to BD.
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Benefits
Performance Bonus
Company News
Vdyne granted IDE to address 'forgotten' valve. Vdyne secures IDE approval to launch a pivotal trial for its TTVR system, positioning itself as a key competitor to Edwards Lifesciences in the growing tricuspid valve replacement market. Omar Ford, Editor-in-Chief, MD+DI, Informa Markets - Engineering April 5, 2026 At a glance. * The tricuspid valve market sees growing competition among top players. * The TTVR system targets patients with severe tricuspid regurgitation. * Edwards' Evoque shows strong data at ACC 75th Annual Expo. Vdyne has been granted an IDE to begin a pivotal trial of its transcatheter tricuspid valve replacement system (TTVR). The device will treat patients suffering from severe tricuspid regurgitation. There is a significant market opportunity for the tricuspid valve, often dubbed the "forgotten valve". "This is a defining milestone for Vdyne and an important step toward bringing a much-needed therapy to patients with severe tricuspid regurgitation," said Mike Buck, Chief Executive Officer. "Our focus now is on disciplined clinical execution and partnering with leading investigators to generate high-quality data that advances the field and improves patient care." Vdyne's TTVR system is designed as a patient-tailored, minimally invasive solution to address the complexities of tricuspid valve anatomy and disease. Since its first-in-human use in November 2023, Vdyne said its TTVR system has been used through clinical studies and compassionate use, providing important insights into procedural performance and clinical outcomes. Vdyne's leading competitors in the TTVR market. Vdyne's IDE comes hot on the heels of Edwards Lifesciences presenting strong data at the American College of Cardiology 75th Annual Scientific Session & Expo. During a late-breaking research session, the Irvine, CA-based company revealed two-year data that show its Evoque TTVR system demonstrated significant and sustained patient benefits. Edwards is first to the market with a TTVR system and secured CE mark for Evoque in October of 2023. It won FDA approval for the device in February of 2024. Edwards, which is on the Top 100 Medical Device Companies list, inherited Envoque when it acquired CardiAQ in 2015 for $400 million. There are other companies that are developing TTVR systems. Medtronic, another firm on the Top 100 Medical Device Companies list, scored a breakthrough designation for the Intrepid TTVR system. Medtronic gained access to Intrepid when it acquired Twelve Inc. for about $458 million in 2015. Editor-in-Chief, MD+DI, Informa Markets - Engineering Omar Ford is a seasoned journalist specializing in medical technology, healthcare innovation, and the medical device and diagnostics industry. As the editor-in-chief of Medical Device + Diagnostics Industry (MD+DI), he has earned a reputation as a leading authority in the field, offering in-depth insights into the latest trends, regulatory changes, and technological advancements shaping the future of healthcare. Omar has been a featured speaker at MD&M and MEDevice events. Omar has written for several publications prior to MD+DI. He is a former contributor at Bioworld Medtech, an online publication owned by Clarivate. He was a general assignment reporter for the Beaufort Gazette and an education and county reporter for the Griffin Daily News. He is the 2001 winner of the Judson Chapman Award from the South Carolina Press Association and the 2003 McClatchy President's Award recipient. Omar has a bachelor's degree in print journalism from the University of South Carolina. Throughout his tenure at MD+DI, Omar has covered a wide array of topics, including medical technology innovations, regulatory affairs, market dynamics, and the growing impact of artificial intelligence in healthcare. Omar is the host of the Let's Talk Medtech podcast.
Every Heartbeat Matters | EMERGENCY USA attends Partner Summit. * April 2, 2026 * Events Last week, an EMERGENCY delegation had the opportunity to attend the Every Heartbeat Matters Partner Summit - hosted by Edwards Lifesciences and the Edwards Lifesciences Foundation - alongside other global partners, clinicians, and advocates who share its belief that access to high-quality cardiac care should never depend on where a person is born. Throughout the Summit, likeminded organizations working across surgery, advocacy, training, and systems strengthening reflected on the incredible strides taken so far, shared current progress and challenges, and highlighted the urgent work ahead. The EMERGENCY team also had the opportunity to take part in a Pro Bono Workshop, collaborating directly with Edwards' employees to identify challenges and build roadmaps for solution implementation. Between 2020 and 2025, partners of Edwards' Every Heartbeat Matters initiative impacted over 3.5 million patients who would otherwise have faced barriers to care. Their 2030 vision aims to reach two million more - and EMERGENCY USA is eager to help achieve that goal. Thank you to Edwards Lifesciences for demonstrating leadership and a strong commitment to equitable cardiac care worldwide. Together, Emergency USA is advancing a world where every heartbeat is valued, and every patient has the right to access quality care, free of charge.
Philips has received FDA 510(k) clearance for EchoNavigator R5.0 with DeviceGuide, a heart procedure visualisation tool developed with Edwards Lifesciences. The system uses artificial intelligence to track and visualise mitral valve repair devices during minimally invasive procedures. The software combines X-ray fluoroscopy and 3D transesophageal echocardiography outputs to continuously show device location, addressing the challenge of interpreting separate images during transcatheter edge-to-edge repair procedures. The system is designed for use with Edwards' Pascal Ace mitral valve repair system. A recent study of 51 patients found over two-thirds of users rated the software helpful or very helpful, with teams reporting improved discussions about optimal device trajectory in 85% of cases. The clearance updates a product originally launched in 2012.
Philips wins FDA clearance for imaging device developed with Edwards. The system uses AI to optimize the placement of Edwards' mitral valve repair device. Published March 27, 2026 Dive brief: * Philips said Thursday it has received 510(k) clearance for a heart procedure visualization tool it developed with Edwards Lifesciences. * The system, called EchoNavigator R5.0 with DeviceGuide, uses artificial intelligence to enable surgeons to track and visualize mitral valve repair devices during minimally invasive heart procedures. * Philips said the system is intended for use with Edwards' Pascal Ace mitral valve repair system, which competes with Abbott's MitraClip for the transcatheter edge-to-edge repair market. Dive insight: Physicians use X-ray fluoroscopy and 3D transesophageal echocardiography to visualize the heart and device during TEER procedures. However, the technologies create two separate images. The surgical team must interpret where the device is in the body based on the two images, potentially leading to miscommunication and suboptimal device placement. Philips designed its software to combine the outputs of the two imaging modalities to continuously show the location of the device in the body. By visualizing the device in the ultrasound image, the companies aim to enable surgeons to more consistently place the repair system in the optimal location. A paper published this month reported the experiences of physicians who used the system to treat 51 patients. More than two-thirds of users said the software was helpful or very helpful. The 4% of users who said the system was not helpful mainly had device recognition issues in patients with multiple heart implants. Teams said the software improved discussions about optimal trajectory in 85% of cases. The Food and Drug Administration clearance, which updates a product that originally launched in 2012, comes four months after Philips said it was working with Edwards. Philips had already filed for 510(k) clearance when it disclosed the alliance. The collaboration combined Philips' imaging and AI capabilities with Edwards' valvular heart therapy expertise. Bert van Meurs, chief business leader of image-guided therapy at Philips, said at the company's capital markets day last month that DeviceGuide is "a concrete example of how we make emerging complex therapies easier to adopt and scale." Developing such products is only possible by partnering with leading companies in the field, such as Edwards, van Meurs said.
Edwards Lifesciences Corporation has completed its transition into a pure-play structural heart disease company following the divestiture of its Critical Care business to Becton, Dickinson and Company for $4.2 billion in cash. The loss of roughly 20% of its 2023 EBITDA has been offset by its Transcatheter Mitral and Tricuspid Therapies segment, which is growing over 50% year-over-year. The company's core Transcatheter Aortic Valve Replacement franchise generates over $4.5 billion in annual revenue with 12%-plus growth. Trading at approximately $78, Edwards Lifesciences maintains 78% gross margins and $3.8 billion in cash. At 21.3 times EV/NTM EBITDA, the valuation sits below its historical average of 26 times, with expected EBITDA growth of 10–11% CAGR. Sixty-four hedge funds held positions at the end of the third quarter.