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Eu Mdr Auditor Jobs (NOW HIRING)

Scarlet

Lead Auditor - Contractor role

EU MDR and/or UK MDR * Prior work with notified bodies or accreditation bodies as a Lead Auditor * Working knowledge of relevant standards, such as: * ISO 14971 * IEC 62304 * IEC 82304

Hologic, Inc.

WI · On-site

$138K - $230K/yr

Active Certification as IRCA, RABQSA, ASQ CMDA (preferred), ISO 13485 Lead Auditor, EU MDR or EU IVDR Lead Auditor Qualification by a recognized organization * Minimum of 8 years of experience in one ...

Apple Inc.

$149K - $249K/yr

Conducts audits in accordance to ISO 13485, MDSAP requirements, China GMP, EU MDR and other ... Lead auditor certification or internal auditor certification * Attention to detail, well organized ...

Apple

Senior Lead Auditor (Medical Devices)

Cupertino, CA · On-site

$99K - $122K/yr

ISO 13485, MDSAP requirements, China GMP, EU MDR, China GMP, etc...) Excellent written and verbal ... auditor certification or internal auditor certification Attention to detail, well organized and ...

Terumo Aortic

NY · On-site

$70K - $91K/yr

This position supports the Quality Compliance workstream for EU MDR submission projects ... Through proactive engagement, auditing, training, and compliance initiatives, this role helps ...

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Eu Mdr Auditor information

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How much do eu mdr auditor jobs pay per hour?

As of Sep 15, 2026, the average hourly pay for eu mdr auditor in the United States is $38.60, according to ZipRecruiter salary data. Most workers in this role earn between $17.31 and $32.69 per hour, depending on experience, location, and employer.

What is an EU MDR auditor?

An EU MDR Auditor is a professional responsible for assessing and ensuring that medical device manufacturers comply with the European Union Medical Device Regulation (EU MDR). They conduct audits of a company's quality management systems, technical documentation, and processes to verify adherence to regulatory requirements. EU MDR Auditors may work for notified bodies, regulatory consultancies, or internally within organizations to help maintain certification and market access in the EU. Their work is critical for ensuring the safety, effectiveness, and compliance of medical devices sold in Europe.

What are the key skills and qualifications needed to thrive as an EU MDR auditor?

To thrive as an EU MDR Auditor, you need a deep understanding of EU Medical Device Regulation, quality management systems (such as ISO 13485), and typically a background in life sciences or engineering. Familiarity with auditing software, document management systems, and relevant certifications like IRCA or RABQSA Lead Auditor qualifications are commonly required. Strong analytical thinking, attention to detail, and effective communication skills help auditors assess compliance and interact with clients. These skills ensure accurate, thorough audits that support regulatory compliance and patient safety in the medical device industry.

What are some typical challenges faced by EU MDR auditors during the certification process?

EU MDR Auditors often encounter challenges such as interpreting the complex and evolving regulatory requirements, ensuring that medical device manufacturers have robust technical documentation, and managing time effectively during intensive audits. Auditors must also navigate varying levels of preparedness among clients and sometimes work with cross-functional teams to clarify compliance expectations. Staying updated with the latest guidance and harmonized standards is essential for effectively addressing these challenges and maintaining high audit quality.

What is the difference between Eu Mdr Auditor vs Notified Body Auditor?

AspectEu Mdr AuditorNotified Body Auditor
CertificationsISO 13485, MDR-specific trainingISO 13485, MDR, Notified Body-specific training
Work EnvironmentMedical device companies, internal auditsNotified bodies, external audits of manufacturers
Industry UsagePrimarily within medical device companies and regulatory bodiesPrimarily within notified bodies assessing compliance

The main difference is that a Eu Mdr Auditor conducts internal or supplier audits to ensure compliance with MDR standards within medical device companies, while a Notified Body Auditor performs external audits on manufacturers to certify compliance for market approval. Both roles require similar certifications but differ in their scope and work environment.

What are popular job titles related to Eu Mdr Auditor jobs?

For Eu Mdr Auditor jobs, the most frequently searched job titles are:

Infographic showing various Eu Mdr Auditor job openings in the United States as of September 2026, with employment types broken down into 91% Full Time, 6% Part Time, 2% Contract, and 1% Nights. Highlights an 85% Physical, 4% Hybrid, and 11% Remote job distribution, with an average salary of $80,278 per year, or $38.6 per hour.

Lead Auditor - Contractor role

Remote

Scarlet
See more jobs at Scarletexternal

Contractor

Re-posted 28 days ago

Job description

We pull medical technology from the future to solve human health.
Scarlet is authorised to assess and certify medical devices. We combine clinical, technical and regulatory expertise with AI agents and software so rigorous certification can keep pace with product development at the world's most ambitious technology companies, without lowering the safety bar.
Our customers have cut a year or more from their certification timelines for new AI-enabled medical devices and shortened product-update cycles from months to weeks. You'll join a team building the infrastructure that makes these outcomes repeatable at scale.
About the role
As a Lead Auditor Contractor at Scarlet, you will independently deliver efficient, high-quality QMS audits that help innovative medical device companies meet the highest regulatory standards.
We're expanding our auditor pool and we're looking for part-time/contractor lead auditors who can independently deliver audits in line with Scarlet's standards, approach and culture.
This role is suited for auditors who fulfil the relevant criteria to be authorised as a Lead Auditor in a Certification or Notified Body under ISO 13485, EU MDR and UK MDR. You will work flexibly, supporting audit delivery as part of Scarlet's notified body activities. This is a fully remote role, with flexible scheduling, subject to audit demand and availability.
Responsibilities
  • 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.
  • Contribute to consistent, high-quality audit experiences aligned with Scarlet's audit methodology and values.

Required qualifications
  • Bachelor's degree in:
    • software engineering
    • computer science
    • physics or biophysics
    • biology or microbiology
    • chemistry or biochemistry
    • electrical, electronic, mechanical engineering or bioengineering
    • human physiology
    • medicine
    • pharmacy
  • Minimum 4 years of experience in the medical device industry
  • Minimum 2 years of experience auditing or managing QMSs under:
    • ISO 13485
    • EU MDR and/or UK MDR
  • Prior work with notified bodies or accreditation bodies as a Lead Auditor
  • Working knowledge of relevant standards, such as:
    • ISO 14971
    • IEC 62304
    • IEC 82304
    • Cybersecurity
  • Evidence of confidently interpreting and applying regulatory requirements.
  • Evidence of delivering consistent, high-quality audits.
  • Ability to explain findings and requirements clearly and constructively.
  • Ability to deliver audits independently with minimal oversight.
  • Willingness to adopt Scarlet's values, audit methods and tooling.

Preferred qualifications
  • Practical experience working with software.
  • Experience with software medical devices (SaMD).

Interview process
  • Introductory call with Emily (30 min)
  • Auditor competence & regulatory interviews (2x30-45 min)
  • References
  • Offer & onboarding

Apply