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Remote Eu Mdr Jobs (NOW HIRING)

Irhythmtech

Manager, Regulatory Affairs

San Francisco, CA · On-site +1

$127K - $165K/yr

Lead EU MDR Technical Documentation and other international submissions for both wearable devices ... Remote - US Actual compensation may vary depending on job-related factors including knowledge ...

LivaNova

Regulatory & Clinical Specialist

Denver, CO · Remote

$85K - $95K/yr

... EU MDR requirements. * Conduct systematic literature searches, appraisal, analysis, and ... This is a remote role (candidates must be based in the United States) * Occasional travel may be ...

LivaNova

Regulatory & Clinical Specialist

Minneapolis, MN · Remote

$85K - $95K/yr

... EU MDR requirements. * Conduct systematic literature searches, appraisal, analysis, and ... This is a remote role (candidates must be based in the United States) * Occasional travel may be ...

LivaNova

Regulatory & Clinical Specialist

Charlotte, NC · Remote

$85K - $95K/yr

... EU MDR requirements. * Conduct systematic literature searches, appraisal, analysis, and ... This is a remote role (candidates must be based in the United States) * Occasional travel may be ...

LivaNova

Regulatory & Clinical Specialist

Boston, MA · Remote

$85K - $95K/yr

... EU MDR requirements. * Conduct systematic literature searches, appraisal, analysis, and ... This is a remote role (candidates must be based in the United States) * Occasional travel may be ...

LivaNova

Regulatory & Clinical Specialist

Phoenix, AZ · Remote

$85K - $95K/yr

... EU MDR requirements. * Conduct systematic literature searches, appraisal, analysis, and ... This is a remote role (candidates must be based in the United States) * Occasional travel may be ...

ARTHREX

Senior Medical Writer (Remote)

OR · On-site +1

Senior Medical Writer (Remote) Arthrex, Inc. is a global medical device company and a leader in new ... EU MDR/MDD experience required. Reasoning Ability: Ability to identify and define problems, collect ...

Dentsply Sirona, Inc

Regulatory Affairs Manager

This position can be a remote working arrangement. Candidates must be located in the US, ideally in ... In-depth knowledge of FDA 510(k) and international regulations (e.g., EN ISO 13485, EU MDR)

Dentsply Sirona

Regulatory Affairs Manager

This position can be a remote working arrangement. Candidates must be located in the US, ideally in ... In-depth knowledge of FDA 510(k) and international regulations (e.g., EN ISO 13485, EU MDR)

Dentsply Sirona

Regulatory Affairs Manager

This position can be a remote working arrangement. Candidates must be located in the US, ideally in ... In-depth knowledge of FDA 510(k) and international regulations (e.g., EN ISO 13485, EU MDR)

Dentsply Sirona, Inc

Regulatory Affairs Manager

This position can be a remote working arrangement. Candidates must be located in the US, ideally in ... In-depth knowledge of FDA 510(k) and international regulations (e.g., EN ISO 13485, EU MDR)

Dentsply Sirona, Inc

Regulatory Affairs Manager

This position can be a remote working arrangement. Candidates must be located in the US, ideally in ... In-depth knowledge of FDA 510(k) and international regulations (e.g., EN ISO 13485, EU MDR)

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Remote Eu Mdr information

See salary details

$40.5K

$95.4K

$138.5K

How much do remote eu mdr jobs pay per year?

As of Jul 14, 2026, the average yearly pay for remote eu mdr in the United States is $95,411.00, according to ZipRecruiter salary data. Most workers in this role earn between $74,500.00 and $112,000.00 per year, depending on experience, location, and employer.

What is the difference between Remote Eu Mdr vs Remote EU Regulatory Affairs Specialist?

AspectRemote Eu MdrRemote EU Regulatory Affairs Specialist
CertificationsISO 13485, MDR compliance trainingISO 13485, MDR, and regulatory affairs certifications
Work EnvironmentRemote, focused on medical device complianceRemote, involved in regulatory submissions and compliance
Industry UsageMedical device manufacturing and complianceMedical device and pharmaceutical industries
Search & Comparison IntentUnderstanding MDR compliance rolesRegulatory affairs roles in EU medical devices

Both roles focus on EU medical device regulations, but Remote Eu Mdr primarily involves ensuring compliance with MDR standards, while Remote EU Regulatory Affairs Specialist handles broader regulatory submissions and industry compliance. The latter often requires additional regulatory certifications and a broader scope of responsibilities.

What is a Remote EU MDR specialist?

A Remote EU MDR specialist is a professional who ensures that medical devices comply with the European Union Medical Device Regulation (EU MDR) while working remotely. Their responsibilities include interpreting EU MDR requirements, guiding companies through compliance processes, preparing and reviewing technical documentation, and liaising with regulatory bodies. They play a crucial role in helping medical device manufacturers bring products to the European market by ensuring products meet safety and performance standards. This role can be performed from any location with reliable internet access, making it suitable for remote work arrangements.

What are some common challenges faced by professionals working as Remote EU MDR specialists, and how can they effectively manage them?

Remote EU MDR specialists often encounter challenges such as staying up-to-date with constantly evolving European medical device regulations, managing communication across international teams, and ensuring timely documentation for regulatory submissions. To effectively manage these challenges, it’s important to establish a structured workflow, leverage collaborative digital tools, and participate in ongoing training or webinars to stay current. Proactive communication with cross-functional teams, such as R&D, quality assurance, and clinical teams, is also essential for successful compliance and project delivery.

What are the key skills and qualifications needed to thrive as a Remote EU MDR Specialist, and why are they important?

To thrive as a Remote EU MDR (Medical Device Regulation) Specialist, you need a solid understanding of EU medical device regulations, quality management systems, and regulatory submission processes, typically supported by a degree in life sciences or engineering. Familiarity with regulatory databases, document control platforms, and certifications like RAC (Regulatory Affairs Certification) are highly beneficial. Strong attention to detail, analytical thinking, and effective communication are crucial for interpreting complex regulations and coordinating with cross-functional teams. These skills ensure compliance with stringent EU standards, minimize regulatory risks, and facilitate successful market access for medical devices.
More about Remote Eu Mdr jobs
What cities are hiring for Remote Eu Mdr jobs? Cities with the most Remote Eu Mdr job openings:
What are the most commonly searched types of Eu Mdr jobs? The most popular types of Eu Mdr jobs are:
What states have the most Remote Eu Mdr jobs? States with the most job openings for Remote Eu Mdr jobs include:
What job categories do people searching Remote Eu Mdr jobs look for? The top searched job categories for Remote Eu Mdr jobs are:
Remote Eu Mdr jobs near you
Infographic showing various Remote Eu Mdr job openings in the United States as of July 2026, with employment types broken down into 4% Locum Tenens, 80% Full Time, 11% Part Time, 1% Temporary, 3% Contract, and 1% Nights. Highlights an 86% Physical, 4% Hybrid, and 10% Remote job distribution, with an average salary of $95,411 per year, or $45.9 per hour.

Manager, Regulatory Affairs

Irhythmtech

San Francisco, CA • On-site, Remote

$127K - $165K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Re-posted 7 days ago

Job description

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

About This Role:

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.

About you:

  • 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%

What's in it for you:

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!

Location:

Remote - US

Actual compensation may vary depending on job-related factors including knowledge, skills, experience, and work location.

Estimated Pay Range

$127,000.00 - $165,000.00

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 taops@irhythmtech.com

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 taops@irhythmtech.com. 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

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