Full-Time

Senior Regulatory Affairs Specialist

iRhythm Technologies

iRhythm Technologies

1,001-5,000 employees

Wearable cardiac monitoring with data analysis

Compensation Overview

$99k - $129k/yr

+ 401(k) company match + Employee Stock Purchase Plan

Remote in USA

Remote

Travel may be required, up to 10%.

Bachelor's, Master's

Category
Legal & Compliance (1)
Required Skills
HIPAA

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Requirements
  • A bachelor's degree is required.
  • At least 3 years of Regulatory Affairs experience in the medical device industry is required.
  • Product development or sustaining/life-cycle management experience is required.
  • Familiarity with global medical device regulations, including 21 CFR 820, MDD/CMDR, European Union Medical Device Regulation, United Kingdom Conformity Assessed, Asia-Pacific, and Latin American regulations, is preferred.
  • Demonstrated understanding of ISO 13485, ISO 14971, ISO 10993, General Data Protection Regulation, Health Insurance Portability and Accountability Act, and other international regulations, directives, and standards is preferred.
  • Exceptional written and oral communication skills are required.
  • Exceptional problem-solving skills are required.
  • Exceptional organizational skills are required.
  • Willingness to travel when required, up to 10%, is required.
Responsibilities
  • Develop global, regional, and multi-country regulatory strategies for new and modified medical devices.
  • Prepare international and domestic filings and registrations according to established timelines and company objectives.
  • Anticipate regulatory and related obstacles and emerging issues throughout the product lifecycle.
  • Interact with regulatory authorities during the development and review process to ensure submission approval.
  • Represent Regulatory Affairs on assigned projects and provide regulatory guidance to cross-functional teams.
  • Coordinate with international contacts on product changes, regulatory notifications, and registration and license maintenance.
  • Review and approve product design changes to maintain regulatory compliance for significant changes.
  • Author or revise standard operating procedures to improve regulatory compliance of the Quality System.
  • Review and approve advertising and promotional items to drive global labeling alignment and market-specific regulatory compliance.
  • Support product recalls and communications for internationally commercialized products.
  • Monitor the impact of changing global regulations on submission strategies and registrations.
  • Perform other assigned quality and regulatory-related duties.
Desired Qualifications
  • A master's or other advanced degree in a related field is preferred.
  • Software as a Medical Device, Medical Device Software, wearable, and over-the-counter medical device experience is highly preferred.
  • Project management skills are preferred.

iRhythm Technologies develops cardiac monitoring technology centered on the Zio Patch, a wearable device that records heart rhythms for up to 14 days. The patch is worn by patients to collect continuous heart data, which iRhythm analyzes and interprets to provide diagnostic insights to clinicians without frequent in-person visits. Compared with rivals, the Zio Patch focuses on long-duration, non-intrusive monitoring combined with integrated data analysis that supports telehealth and clinician workflows. Its goal is to improve arrhythmia detection and diagnostic accuracy while streamlining patient care through scalable wearable monitoring and data interpretation.

Company Size

1,001-5,000

Company Stage

IPO

Headquarters

San Francisco, California

Founded

2006

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Simplify Jobs

Simplify's Take

What believers are saying

  • Q2 2026 revenue hit $224.2 million, up 20.1%, with record $37.5 million free cash flow.
  • Management raised 2026 revenue guidance to $880 million-$890 million and EBITDA margin to 13%-14%.
  • VitalConnect's $65 million run rate and 2027 contribution expand growth optionality across care settings.

What critics are saying

  • June 2026 cyberattack exfiltrated patient and proprietary data, threatening trust and regulatory scrutiny.
  • July 31, 2026 Baxter settlement cost $50 million, exposing lingering IP and commercialization disputes.
  • FDA warning-letter remediation still shadows Zio operations; any renewed enforcement would hit launches and reimbursement.

What makes iRhythm Technologies unique

  • Zio remains a dominant 14-day ambulatory patch, driving seventh straight 20% growth quarter.
  • iRhythm couples wearable monitoring with AI analysis, improving workflow efficiency and technician review time.
  • VitalConnect adds FDA-cleared MCT and hospital monitoring, broadening iRhythm beyond Zio.

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Benefits

Health Insurance

Dental Insurance

Vision Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Holidays

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Mental Health Support

Hybrid Work Options

Pet Insurance

Growth & Insights and Company News

Headcount

6 month growth

0%

1 year growth

0%

2 year growth

0%
Yahoo Finance
Aug 15th, 2026
iRhythm beats Q2 revenue by 2.3%, adjusted EBITDA surges 65.7% to $43.3M

iRhythm reported strong second-quarter results, beating analyst estimates with revenue of $224.2 million, up 20.1% year-on-year. The cardiac monitoring company posted adjusted earnings per share of $0.58, significantly exceeding the $0.04 estimate. Adjusted EBITDA reached $43.3 million, a 65.7% beat against expectations. Management attributed the performance to sustained demand for the Zio platform and effective commercial execution across multiple healthcare channels. During the earnings call, analysts questioned management about synergies from the VitalConnect acquisition and the sustainability of margin gains. CEO Quentin Blackford emphasised the need for a multi-product approach in the cardiac monitoring market. The company raised its full-year revenue guidance to $885 million from $880 million. Operating margin improved to -1.1% from -10% in the prior-year quarter.

Yahoo Finance
Aug 12th, 2026
iRhythm shares fall 1.9% despite strong Q2 earnings after Truist slashes price target from $160 to $18

iRhythm Technologies shares fell 1.9% to $125.41 after Truist Securities slashed its price target from $160 to $18, despite maintaining a Buy rating. The dramatic cut overshadowed the company's strong second-quarter results, which saw revenue of $224.2 million, up 20.1% year-over-year, and earnings per share of $0.58, significantly beating consensus estimates. Following the earnings beat, iRhythm raised its full-year revenue guidance to $885 million at the midpoint. The cardiac monitoring company has experienced volatile trading, with 19 moves greater than 5% over the past year. iRhythm is down 28.4% year-to-date and trading 33.7% below its 52-week high of $189.25.

Yahoo Finance
Aug 10th, 2026
iRhythm beats Q2 estimates with $224M revenue and 19.3% EBITDA margin as cardiac monitoring platform gains traction

iRhythm Technologies reported second-quarter revenue of $224.2 million, up 20.1% year-on-year and beating analyst estimates of $219.2 million. The medical technology company's non-GAAP profit of $0.58 per share significantly exceeded consensus forecasts. The company attributed the performance to sustained demand for its Zio ambulatory cardiac monitoring platform and effective commercial execution across cardiology, primary care, and new healthcare channels. Operating margin improved to -1.1% from -10% in the prior-year quarter, driven by manufacturing automation and workflow optimisation. iRhythm raised its full-year revenue guidance to $885 million from $880 million. The company plans to leverage its pending VitalConnect acquisition to expand into mobile cardiac telemetry and remote patient monitoring markets.

MD+DI
Aug 7th, 2026
Following cyberattack recovery, iRhythm announces major acquisition & strong 2Q26 results.

Following cyberattack recovery, iRhythm announces major acquisition & strong 2Q26 results. iRhythm reports 20% revenue growth, settles Baxter suit, and is set to acquire VitalConnect for $287.5 million. Omar Ford, Editor-in-Chief, MD+DI, Informa Markets - Engineering August 7, 2026 There was a lot to digest in iRhythm Technologies' 2Q26 earnings. Revenue was up by 20.1% year-over-year; the company resolved litigation with Baxter; and provided an update on its recovery from a cyberattack in June. But the biggest news from the firm's earnings call was its plan to acquire VitalConnect for $237.5 million in cash and about $50 million in iRhythm common stock. The deal is set to close by the end of the year. San Jose, CA-based VitalConnect is a private wearable biosensor technology company with a strong focus on the mobile cardiac telemetry (MCT) market. It operates an FDA-cleared platform that spans multiple cardiac monitoring modalities and multi-vitals monitoring capabilities designed for hospital and remote care settings. The company's biosensor platform can monitor up to 11 physiological parameters. "The strategic fit is compelling," said Quentin Blackford, president and CEO of iRhythm, according to a Seeking Alpha transcript of the earnings call. "Vital Connect reinforces our commitment to innovation in ambulatory cardiac monitoring and adds an FDA-cleared platform with a patient monitoring service up to 30 days, 4-in-1 device functionality, flexible service models, live-looking capabilities, and multivital monitoring." According to the Seeking Alpha transcript, he added, "These features complement our existing portfolio and give us additional tools to meet different clinical, operational, and economic needs of customers and patients. This acquisition also expands our ability to participate in the MCT segment." The company said it expects the acquisition to positively contribute to revenue growth beginning in 2027. iRhythm executives noted Vital Connect is currently at an approximately $65 million annual revenue run rate. "By combining our flexible biosensor platform, AI-enabled algorithms and streamlined workflows with iRhythm's commercial scale and reach, we intend to bring a more compelling portfolio to a larger base of customers and patients than either company could deliver independently," Peter Van Haur, CEO of VitalConnect Together, MD+DI expect to unlock new growth opportunities across ambulatory cardiac monitoring, inpatient monitoring and hospital-to-home care." BTIG analysts sound off on iRhythm's acquisition. Marie Thibault, an analyst with BTIG, wrote the deal was surprising and offered commentary on how investors might view the acquisition. "We expect investor views of the deal to be mixed, with the obvious concern being that this might be an attempt to disguise an underlying slowdown in the MCT segment," she wrote in a research note. "There may also be some concern about iRhythm's ability to sell two products simultaneously in the MCT market or whether the Zio MCT product is underwhelming. We acknowledge these issues but also believe iRhythm had previously appraised and liked the technology and that timing of the deal may be down to opportunity matched with VitalConnect's capital needs timeline." News of the pending acquisition and the 2Q26 earnings helped boost iRhythm's shares up by more than 2% in after-hours trading. iRhythm's cyberattack recovery. The deal comes nearly two months after the firm announced it received a notice from a "threat actor" that it had obtained protected patient information, including proprietary data, patient protected health information, and other personal information. The cyberterror organization demanded payment from iRhythm in exchange for not leaking the data. The company confirmed that the cyberterror group did obtain sensitive information. "The incident has been contained and the root cause identified," Blackford said, according to a Seeking Alpha transcript of the call. "While certain data was exfiltrated, our investigation and remediation actions resulted in no material impacts to our products, patient care, business operations or financial results." 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. Want more MD+DI in your search results?

Yahoo Finance
Aug 6th, 2026
iRhythm beats Q2 revenue expectations with $224.2M, up 20.1% year-on-year

iRhythm Technologies reported second-quarter revenue of $224.2 million, beating analyst estimates of $219.2 million and representing 20.1% year-on-year growth. The medical technology company, which provides wearable cardiac monitoring devices and AI-powered analysis services, also exceeded profit expectations with non-GAAP earnings of $0.58 per share. The company raised its full-year revenue guidance to $885 million from $880 million, aligning closely with analyst forecasts. Operating margin improved to -1.1%, up from -10% in the same quarter last year. Chief Executive Quentin Blackford attributed the results to strong execution and progress against strategic priorities. Analysts project 14.7% revenue growth over the next 12 months.