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Remote Eu Mdr Jobs (NOW HIRING)

Sonova AG

Specialist II, Regulatory Affairs

$75K - $112K/yr

... FDA, EU MDR, etc.) preferred. * Strong knowledge of regulatory requirements, standards, and ... any remote/hybrid employee functionality at Sonova Don't meet all the criteria? If you're willing ...

EnsoData

Backend Software Engineer

Madison, WI · On-site +1

Knowledge of medical device regulations (FDA Class II/III, EU MDR). * Understanding of software ... Remote and flexible schedule - we are a remote company with hybrid options and support for flexible ...

BSI Group

Medical Device QMS Auditor

Concord, NC · Remote

$98K - $123K/yr

... EU MDR/IVDR are a plus Core Competencies * Strong verbal and written communication skills, and ... LI-REMOTE #LI-MS1 About Us BSI is a business improvement and standards company and for over a ...

Merative

Sr Specialist, Continuous Improvement- SaMD

$102K - $153K/yr

Familiarity with regulatory requirements including 21 CFR Part 820, SOR/98-282, and EU MDR (2017 ... Office environment, or remote work-from-home. * Travel: ~5% Compensation The salary range provided ...

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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 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:
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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.

Head of Quality Engineering & Regulatory Affairs

Stirling QR

Menlo Park, CA • On-site, Remote

$170K - $200K/yr

Full-time

Re-posted 21 hours ago

Job description

About the company:

Our client is a world leader in applying deep learning to medical image acquisition to enable faster, safer and smarter medical imaging. They deliver responsible AI solutions that measurably improve radiology workflows and patient experience, with a vision that every person has access to timely diagnosis, highquality care and a longer, healthier life. They have multiple FDAcleared and CEmarked AI software products in routine clinical use across hundreds of hospitals and imaging centers worldwide, backed by a robust multimodality pipeline and strong investment in R&D. The team includes leading radiologists, scientists and engineers from top universities, many from major imaging OEMs, and the company has been repeatedly recognized as a top global AI and digital health company. They operate as an equal opportunity employer.

About the role:

The Head of Quality Engineering & Regulatory Affairs (Head of QERA) is a key executive reporting to the Chief Product Officer, responsible for building, leading and maintaining the company’s Quality and Regulatory Affairs functions and systems. The role owns the quality and regulatory strategy that enables global commercialization of AI/ML SaMD products and serves as both Management Representative (MR) and Person Responsible for Regulatory Compliance (PRRC). This position can be remote in the US or hybrid in the San Francisco Bay Area, includes up to 30% travel for audits and leadership meetings, and offers H1B sponsorship.

Key Responsibilities:

  • Lead the development, implementation, maintenance and continuous improvement of the company’s quality and regulatory programs and strategies.
  • Define quality standards and objectives, embed quality into product development and deployment processes, and oversee vendor/supplier quality.
  • Develop and execute a global regulatory compliance strategy aligned with business and commercialization goals for AI/ML SaMD.
  • Own and support QMS processes, ensuring regulated systems and documentation are inspectionready at all times.
  • Partner with R&D, Product, Engineering and Marketing to enable timely global market access and lifecycle management of products.
  • Plan and oversee internal and external audits and regulatory inspections, including followup and effectiveness of CAPAs.
  • Maintain and improve departmental policies and procedures (including training, CAPAs, ECRs, ECNs) and drive timely closure.
  • Build and develop the QERA organization, including people, processes and tools, to meet near and longterm objectives.
  • Ensure Quality System compliance with FDA 21 CFR Part 820, EU MDR and other relevant global regulations and standards.
  • Act as MR and PRRC and support data protection activities such as audits, investigations and training across PHI, customer, HR, financial and proprietary data.
  • Provide executivelevel reporting on quality and regulatory performance, risks and mitigation plans.

Key requirements:

  • Bachelor’s degree in a scientific, engineering or related discipline required; Master’s degree a plus.
  • Senior leadership experience in QA/RA within medical devices, SaMD or related regulated healthcare domains.
  • Demonstrated experience hosting regulatory inspections and interacting with regulators/notified bodies.
  • Handson experience with CSV and implementation of QMS and ERP software (requirements, specifications, workflows, validation, IQ/OQ/PQ).
  • Solid understanding of ICH, cGMP, cGDP, FDA, ISO, MDR, healthcare compliance and regulations for clinical research and medical devices.
  • Proficiency with ISO 13485, GCP, QSIT and relevant CFR parts (including 210, 211 and 820), plus ISO 14971, IEC 62304 and IEC 62366.
  • Strong track record of successful global registrations and market access.
  • Proven ability to build a culture of accountability, ownership and continuous improvement and to work effectively in a matrixed, crossfunctional environment.
  • Excellent written and verbal communication skills, strong analytical and problemsolving capabilities, and high independence with strong team integration.