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Remote Eu Mdr Jobs (NOW HIRING)

Scarlet

Lead Auditor - Contractor role

Conduct remote audits of medical device manufacturers' Quality Management Systems under ISO 13485, EU MDR, and UK MDR. * Provide clear, structured audit documentation and evidence-based conclusions.

Getinge

Medical Writer (Remote, US)

Boston, MA · On-site +1

Contributes to the Summary of Safety and Clinical Performance in alignment with EU MDR. * Serves as ... LI-remote About us With a firm belief that every person and community should have access to the ...

Jobgether

You will work with a flexible contractor model, delivering remote audits while applying your expertise in ISO 13485, EU MDR, and UK MDR requirements. The position offers the chance to contribute to ...

New

Getinge

Medical Writer (Remote, US)

Boston, MA · On-site +1

Contributes to the Summary of Safety and Clinical Performance in alignment with EU MDR. * Serves as ... LI-remote About us With a firm belief that every person and community should have access to the ...

LivaNova

Regulatory & Clinical Specialist

Dallas, TX · 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

Houston, TX · 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

Chicago, IL · 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

Atlanta, GA · 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

Austin, TX · 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 ...

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All JobsEu Mdr JobsRemote Eu Mdr Jobs

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 13, 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.

Remote Regulatory Affairs contractor

Globalchannelmanagement

Atlanta, GA • Remote

$99 - $100/hr

Full-time

Posted 16 days ago

Job description

Remote Regulatory Affairs contractor requires:

  • Bachelor's degree in engineering, life sciences, regulatory affairs, legal or a related field
  • 5-10 years+ of global medical device regulatory experience
  • Proven experience preparing, writing and submitting FDA 510k submissions (end to end)
  • Experience with ophthalmic devices, capital equipment, diagnostic devices, software in medical devices, cybersecurity
  • Strong working knowledge of:
    • FDA regulations (21 Parts 807, 820)
    • FDA guidance documents and eStar requirements
    • Experience with Canadian regulations, EU MDR (2017/745) including Class lla, Tech docs Annex ll/lll
  • Demonstrated ability to work independently as a contractor in a fast-paced environment
  • Experience filing medical device submissions in China and other countries
  • Experience with audiology devices
  • Experience with artificial-intelligence enabled devices
  • Strong technical writing and documentation skills
  • Ability to translate complex technical information into regulatory submissions
  • Detail-oriented with strong organization skills
  • Effective communicator across technical and non-technical stakeholders
  • Ability to manage multiple deliverables and timelines

DUTIES:

  • FDA 510(k) submission
  • Conduct comprehensive review of technical documentation (design controls, V&V, risk, labeling, clinical evidence, and software as applicable) to ensure completeness, quality, and regulatory compliance
  • Perform detailed regulatory gap assessments against FDA requirements (21 CFR Parts 807, 820, and applicable FDA guidance documents)
  • Author, compile and deliver a complete 510k submission, including preparation in FDA eSTAR format,
  • Lead submission lifecycle activities, including:
    • Acceptance Review support (RTA readiness)
    • Substantive Review coordination
    • Drafting and submission of responses to FDA requests for Additional Information, Interactive review communications
    • Updating submission content and modules as required
  • Interface cross-functionally to incorporate Business inputs and ensure alignment throughout the review process.
  • Provide regulatory leadership through FDA clearance.
  • EU MDR Technical Documentation Support
  • Conduct EU MDR readiness assessment aligned with Notified Body expectations and conformity assessment requirements.
  • Perform critical review and gap analysis of EU MDR technical file
  • Provide targeted recommendations to ensure audit-readiness and Notified Body acceptance
  • Lead or support submission to obtain CE Mark
  • Health Canada submission
  • Global Regulatory Strategy and Advisory