New · posted Oct 15
iRhythm · Medical Devices
Manager, Regulatory Affairs
- Remote, US
- Remote
- Full-time
- Manager
Open until filled
The role
Career-defining. Life-changing.
At iRhythm, you’ll have the opportunity to grow your skills and your career while impacting the lives of people around the world. iRhythm is shaping a future where everyone, everywhere can access the best possible cardiac health solutions. Every day, we collaborate, create, and constantly reimagine what’s possible. We think big and move fast, driven by our commitment to put patients first and improve lives. We need builders like you. Curious and innovative problem solvers looking for the chance to meaningfully shape the future of cardiac health, our company, and your career
Responsibilities include:
- Developing and executing regulatory strategies for new and modified medical devices in line with business objectives
- Manage regulatory associates as needed, responsible for team’s work planning, guidance, execution and talent development
- Lead FDA submissions (510(k) or pre-submissions) with the team, including wearable devices, as well as artificial intelligence (AI) Software as a Medical Device (SaMD) products
- Key Regulatory SME and review & approve advertising and promotional materials to ensure regulatory compliance
- Regulatory strategy and processes for product life cycle management
- Lead EU MDR Technical Documentation and other international submissions for both wearable devices and SaMD
- Developing regulatory tools and matrices to enhance team efficiency and capabilities as needed
- Lead regulatory expert in AI, SaMD, Cybersecurity, collaborating with stakeholders establishing necessary processes to ensure regulation compliance
- Preparing international and domestic regulatory filings/registrations in line with established project timelines
- Interacting with regulatory authorities during the development and review process to ensure submission clearance
- Review and approve product design changes to maintain regulatory compliance for significant changes
- Author or revise SOPs to improve regulatory compliance within the Quality System
- Monitoring the impact of changing global regulations on submission strategies & registrations
- Support external and internal audits
- Perform other regulatory-related duties as assigned.
What you need
- BA or BS degree in engineering, life sciences, or a related field required.
- > 8-10 years minimum of US and/or EU regulatory affairs experience with a Bachelor’s degree; 6 years minimum of US and/or EU regulatory affairs experience with a Master’s degree
- Demonstrated competency in operating under 21 CFR 820, EU MDD/MDR, ISO 13485, IEC 62304, ISO 14971, HIPAA and other medical device industry standards
- Software as a medical device (SaMD) experience required
- New product development experience required
- Authorship of 510(k)s and experience with management of FDA reviews to gain clearance required
- Demonstrated competency in developing risk based regulatory strategies required
- Wearable medical device experience preferred
- Familiarity with global medical device regulations (LATAM, Asia Pac, EMEA, etc.) preferred
- Audit support experience preferred
- Strong project management skills
- Exceptional problem-solving skills
- Exceptional organizational skills
- Exceptional communication (written and oral) skills
- Willingness to travel when required, approximately 5-10%
Skills named in this posting
Pay
$127,000 – $165,000 a year
Employer providedEstimated Pay Range
$127,000.00 - $165,000.00
This is a full-time position with competitive salary package and excellent benefits including medical, dental and vision insurance, paid holidays and paid time off.
iRhythm also provides additional benefits including 401K (w/ company match), an Employee Stock Purchase Plan, annual organizational/cultural committee events and more!
Working conditions
Location
Remote - US
Actual compensation may vary depending on job-related factors including knowledge, skills, experience, and work location.
From the posting
About iRhythm
About iRhythm Technologies
iRhythm is a leading digital healthcare company that creates trusted solutions that detect, predict, and prevent disease. Combining wearable biosensors and cloud-based data analytics with powerful proprietary algorithms, iRhythm distills data from millions of heartbeats into clinically actionable information. Through a relentless focus on patient care, iRhythm’s vision is to deliver better data, better insights, and better health for all.
Make iRhythm your path forward. Zio, the heart monitor that changed the game.
There have been instances where individuals not associated with iRhythm have impersonated iRhythm employees pretending to be involved in the iRhythm recruiting process, or created postings for positions that do not exist. Please note that all open positions will always be shown here on the iRhythm Careers page, and all communications regarding the application, interview and hiring process will come from a @irhythmtech.com email address. Please check any communications to be sure they come directly from @irhythmtech.com email address. If you believe you have been the victim of an imposter or want to confirm that the person you are communicating with is legitimate, please contact [email protected]. Written offers of employment will be extended in a formal offer letter from an @irhythmtech.com email address ONLY.
For more information, see https://www.ftc.gov/business-guidance/blog/2023/01/taking-ploy-out-employment-scams and https://www.ic3.gov/Media/Y2020/PSA200121
Equal opportunity, accessibility and legal noticesiRhythm's statements, word for word
As a part of our core values, we ensure an inclusive workforce. We welcome and celebrate people of all backgrounds, experiences, skills, and perspectives. iRhythm Technologies, Inc. is an Equal Opportunity Employer. We will consider for employment all qualified applicants with arrest and conviction records in accordance with all applicable laws.
iRhythm provides reasonable accommodations for qualified individuals with disabilities in job application procedures, including those who may have any difficulty using our online system. If you need such an accommodation, you may contact us at [email protected]
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 10% below the US median for Regulatory Affairs roles at this level.
This roleEmployer provided
Manager roles in the US47 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $127,000 | — | $165,000 |
| All US (middle half) | $146,750 | $162,500 | $177,750 |
This role: iRhythm's own published range. Comparisons: the base pay employers published on open Regulatory Affairs roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Affairs
The general path across 290 open Regulatory Affairs roles on Regulatory Jobs, with the titles they carry most. Not iRhythm's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 33 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance9
- Regulatory submissions7
- Collaboration and leadership7
- Documentation and SOPs2
- Quality systems and risk2
- Data and digital systems2
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices
- European UnionEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
- ISOISO 14971(official source, opens in a new tab)Risk management for medical devices
- IECIEC 62304(official source, opens in a new tab)Software life cycle processes for medical device software
- FDAFDA 510(k)(official source, opens in a new tab)Premarket notification for medical devices
Company hiring pulse
iRhythm on Regulatory Jobs
- 6
- Open roles
- 6
- Distinct roles
- 3
- Locations
By discipline
- Quality5 83%
- Regulatory1 17%
By level
- Manager2 33%
- Senior & Principal2 33%
- Director1 17%
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Manager, Regulatory Affairs at iRhythm
Open until filled. $127K–$165K a year, employer provided.