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Remote Medical Device Auditor Jobs (NOW HIRING)

As a Medical Device Auditor, you'll travel to medical device manufacturers across Europe, Middle East and Africa and occasionally USA. You'll help these manufacturers to improve their performance by ...

As a Medical Device Auditor, you'll travel to medical device manufacturers across Europe, Middle East and Africa and occasionally USA. You'll help these manufacturers to improve their performance by ...

The Contract Medical Device Auditor is responsible for collecting and analyzing sufficient information to provide a recommendation for certification. * Perform audits for clients' medical device ...

Medical Device QMS Auditor

Concord, NC ยท Remote

$98K - $123K/yr

Job Title: Medical Device QMS Auditor Location: Candidates must reside in one of the following ... LI-REMOTE #LI-MS1 About Us BSI is a business improvement and standards company and for over a ...

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Remote Medical Device Auditor information

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How much do remote medical device auditor jobs pay per hour?

As of Jun 30, 2026, the average hourly pay for remote medical device auditor in the United States is $21.62, according to ZipRecruiter salary data. Most workers in this role earn between $17.31 and $27.40 per hour, depending on experience, location, and employer.

What are some common challenges faced by Remote Medical Device Auditors, and how can they be managed?

Remote Medical Device Auditors often face challenges such as ensuring thorough compliance assessments without on-site access and effectively communicating with diverse client teams across different time zones. To manage these challenges, auditors leverage robust virtual collaboration tools, detailed documentation, and clear communication protocols. Staying up to date with evolving regulatory standards and maintaining strong organizational skills are also critical for success in this role. Proactive planning and flexibility help auditors adapt to varied client needs and maintain audit quality remotely.

What are the key skills and qualifications needed to thrive as a Remote Medical Device Auditor, and why are they important?

To thrive as a Remote Medical Device Auditor, you need a solid understanding of medical device regulations (such as ISO 13485, FDA 21 CFR Part 820), quality management systems, and relevant industry experience, often supported by a degree in science, engineering, or a related field. Familiarity with auditing software, remote communication tools, and recognized auditor certifications (like IRCA or ASQ) is typically required. Strong attention to detail, analytical thinking, and effective communication are essential soft skills for evaluating compliance and collaborating with client teams remotely. These competencies ensure thorough, accurate audits and help organizations maintain regulatory compliance and uphold product safety standards.

What are Remote Medical Device Auditors?

Remote Medical Device Auditors are professionals who evaluate medical device manufacturers' compliance with regulatory standards and quality systems, such as ISO 13485, without being physically present at the site. They conduct audits using digital tools, video conferencing, and document reviews to ensure products meet safety and quality requirements. This role requires strong knowledge of medical device regulations and excellent communication skills to work effectively with clients and regulatory bodies from a distance.
More about Remote Medical Device Auditor jobs
What cities are hiring for Remote Medical Device Auditor jobs? Cities with the most Remote Medical Device Auditor job openings:
What are the most commonly searched types of Medical Device Auditor jobs? The most popular types of Medical Device Auditor jobs are:
What states have the most Remote Medical Device Auditor jobs? States with the most job openings for Remote Medical Device Auditor jobs include:
What job categories do people searching Remote Medical Device Auditor jobs look for? The top searched job categories for Remote Medical Device Auditor jobs are:
Infographic showing various Remote Medical Device Auditor job openings in the United States as of June 2026, with employment types broken down into 75% Full Time, and 25% Part Time. Highlights an 37% Physical, 3% Hybrid, and 60% Remote job distribution, with an average salary of $44,967 per year, or $21.6 per hour.

Japan medical device QMS 13485 auditor (relocation)

BSI Prof Serv EHS West

Concord, NC โ€ข On-site, Remote

Other

Posted 7 hours ago


Key responsibilities

  • Conduct audits of ISO 13485 quality management systems at medical device manufacturers on site or remotely.

  • Write audit reports and liaise with the planning team to manage the audit schedule.

  • Advocate for the ISO 13485 EMEA Delivery Team and continue development related to MDR.


Job description

Great that you're thinking about a career with BSI!

ISO
18081,000
1901ISO90
ISO 13485 QMS

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Medical Device 13485 Auditor in Japan /relocate to Japan(homebased)

We are looking for the candidate who is active searching this relocation opportunity in Japan.

As a Medical Device Auditor, you'll travel to medical device manufacturers across Europe, Middle East and Africa and occasionally USA. You'll help these manufacturers to improve their performance by assessing their ISO 13485 quality management system, so they can ensure patient safety and comply with regulatory procedures.

In the first six months of being a Medical Device Auditor you'll:

  • Be given training in ISO 13485 Lead Auditor training, MDSAP (Medical Device Single Audit Programme) and MDR (Medical Device Regulation)

  • Initially observe how audits are conducted but then grow to conduct them on an individual basis on site at medical device manufacturers across EMEA and remotely from your home office.

In a typical week after being fully trained you'll:

  • Conduct an audit on site or remotely

  • Write up your reports and liaise with the planning team to manage your audit schedule.

  • You'll also continue your development of MDR and be an advocate for the ISO 13485 EMEA Delivery Team.

To thrive in this career, you must:

  • Have 4 years or more being directly accountable for the design or test or manufacture of different medical devices.

  • Be degree educated with discipline relevant to Medical Devices e.g. chemistry, physical chemistry, molecular genetics, textiles, material science, biology, biotechnology or similar.

  • Have at least 2 years' experience working in an environment with a Quality Management System established.

  • Be able to speak and write fluently in the Japanese and English language.

  • Be resilient and able to meet audit delivery by travelling frequently across the EMEA region as required

We're enthusiastic to receive applications from those based in Japan/ relocate to Japan excited by this career opportunity.

#LI-VW

Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business.

BSI is an Equal Opportunity Employer and we are committed to diversity.

BSI is conducting face-to-face interviews where appropriate and possible. If you are invited to a face-to-face interview but feel more comfortable with conducting the interview virtually, please speak to a member of our recruitment team.