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 ...
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 ...
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 ...
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 ...
Excellent knowledge of 21 CFR Part 820, ISO 13485:2016, EU MDR, and MDSAP regulations, with demonstrated experience auditing suppliers to these standards. * ISO 13485 Lead Auditor Certification.
Excellent knowledge of 21 CFR Part 820, ISO 13485:2016, EU MDR, and MDSAP regulations, with demonstrated experience auditing suppliers to these standards. * ISO 13485 Lead Auditor Certification.
Excellent knowledge of 21 CFR Part 820, ISO 13485:2016, EU MDR, and MDSAP regulations, with demonstrated experience auditing suppliers to these standards. * ISO 13485 Lead Auditor Certification.
Excellent knowledge of 21 CFR Part 820, ISO 13485:2016, EU MDR, and MDSAP regulations, with demonstrated experience auditing suppliers to these standards. * ISO 13485 Lead Auditor Certification.
Senior Audit Program Specialist
$81K - $112K/yr
This role is responsible for supporting the auditor team in coordinating and administering all ... Experience with FDA QMSR, ISO 13485, MDSAP * Strong organization and communication skills
Senior Audit Program Specialist
$81K - $112K/yr
This role is responsible for supporting the auditor team in coordinating and administering all ... Experience with FDA QMSR, ISO 13485, MDSAP * Strong organization and communication skills
Senior Audit Program Specialist
$81K - $112K/yr
This role is responsible for supporting the auditor team in coordinating and administering all ... Experience with FDA QMSR, ISO 13485, MDSAP * Strong organization and communication skills
Senior Audit Program Specialist
$81K - $112K/yr
This role is responsible for supporting the auditor team in coordinating and administering all ... Experience with FDA QMSR, ISO 13485, MDSAP * Strong organization and communication skills
Senior Audit Program Specialist
$81K - $112K/yr
This role is responsible for supporting the auditor team in coordinating and administering all ... Experience with FDA QMSR, ISO 13485, MDSAP * Strong organization and communication skills
Senior Audit Program Specialist
$81K - $112K/yr
This role is responsible for supporting the auditor team in coordinating and administering all ... Experience with FDA QMSR, ISO 13485, MDSAP * Strong organization and communication skills
Senior Audit Program Specialist
$81K - $112K/yr
This role is responsible for supporting the auditor team in coordinating and administering all ... Experience with FDA QMSR, ISO 13485, MDSAP * Strong organization and communication skills
Senior Audit Program Specialist
$81K - $112K/yr
This role is responsible for supporting the auditor team in coordinating and administering all ... Experience with FDA QMSR, ISO 13485, MDSAP * Strong organization and communication skills
Excellent knowledge of 21 CFR Part 820, ISO 13485:2016, EU MDR, and MDSAP regulations, with demonstrated experience auditing suppliers to these standards. * ISO 13485 Lead Auditor Certification.
Excellent knowledge of 21 CFR Part 820, ISO 13485:2016, EU MDR, and MDSAP regulations, with demonstrated experience auditing suppliers to these standards. * ISO 13485 Lead Auditor Certification.
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 ...
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 ...
Senior Audit Program Specialist
Plainsboro, NJ · On-site
$81K - $112K/yr
This role is responsible for supporting the auditor team in coordinating and administering all ... Experience with FDA QMSR, ISO 13485, MDSAP * Strong organization and communication skills
Senior Audit Program Specialist
Plainsboro, NJ · On-site
$81K - $112K/yr
This role is responsible for supporting the auditor team in coordinating and administering all ... Experience with FDA QMSR, ISO 13485, MDSAP * Strong organization and communication skills
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 ...
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 ...
Quality Systems Engineer
San Diego, CA · On-site
Strong knowledge of FDA QMSR, ISO 13485, EU MDR, MDSAP and other applicable standards. * 2 years auditing per ISO and/or FDA standards, including direct involvement with external regulatory audits ...
Quality Systems Engineer
San Diego, CA · On-site
Strong knowledge of FDA QMSR, ISO 13485, EU MDR, MDSAP and other applicable standards. * 2 years auditing per ISO and/or FDA standards, including direct involvement with external regulatory audits ...
Quality Systems Engineer
San Diego, CA · On-site
Strong knowledge of FDA QMSR, ISO 13485, EU MDR, MDSAP and other applicable standards. * 2 years auditing per ISO and/or FDA standards, including direct involvement with external regulatory audits ...
Quick apply
Quality Systems Engineer
San Diego, CA · On-site
Strong knowledge of FDA QMSR, ISO 13485, EU MDR, MDSAP and other applicable standards. * 2 years auditing per ISO and/or FDA standards, including direct involvement with external regulatory audits ...
Maintenance of FDA/MDSAP, ISO, and MDD/MDR compliance. * Work with Engineering and Quality ... Work directly with internal auditors and quality managers on compliance related matters. * Maintain ...
Maintenance of FDA/MDSAP, ISO, and MDD/MDR compliance. * Work with Engineering and Quality ... Work directly with internal auditors and quality managers on compliance related matters. * Maintain ...
... auditing the specific device risk classification and technology relevant to our product portfolio. • Familiarity with MDSAP requirements. Key Competencies: • BSI Audit Readiness & Notified Body ...
Quick apply
... auditing the specific device risk classification and technology relevant to our product portfolio. • Familiarity with MDSAP requirements. Key Competencies: • BSI Audit Readiness & Notified Body ...
... auditing, and risk management activities with respect to global regulatory requirements and MDSAP (FDA, ISO, EU MDR, ANVISA, MHLW, and TGA). General Duties and Responsibilities : * Ensure the ongoing ...
... auditing, and risk management activities with respect to global regulatory requirements and MDSAP (FDA, ISO, EU MDR, ANVISA, MHLW, and TGA). General Duties and Responsibilities : * Ensure the ongoing ...
Quality Engineering Manager
Allen, TX · On-site
... auditing, and risk management activities with respect to global regulatory requirements and MDSAP (FDA, ISO, EU MDR, ANVISA, MHLW, and TGA). General Duties and Responsibilities : * Ensure the ongoing ...
Quality Engineering Manager
Allen, TX · On-site
... auditing, and risk management activities with respect to global regulatory requirements and MDSAP (FDA, ISO, EU MDR, ANVISA, MHLW, and TGA). General Duties and Responsibilities : * Ensure the ongoing ...
Certification Project Manager - Medical Devices
Rockville, MD · On-site
$80K - $90K/yr
An Auditing Organization recognized by the MDSAP Regulatory Authority Council. We serve the Medical Device Industry with offices in Europe and the United States. Our goal is to provide the best in ...
Quick apply
Certification Project Manager - Medical Devices
Rockville, MD · On-site
$80K - $90K/yr
An Auditing Organization recognized by the MDSAP Regulatory Authority Council. We serve the Medical Device Industry with offices in Europe and the United States. Our goal is to provide the best in ...
Manager, Regulatory Compliance
$104K - $161K/yr
Lead and coordinate external inspections and audits by regulators, Notified Bodies, and MDSAP Auditing Organizations, including front-room/back-room operations and rapid response management. * Lead ...
Manager, Regulatory Compliance
$104K - $161K/yr
Lead and coordinate external inspections and audits by regulators, Notified Bodies, and MDSAP Auditing Organizations, including front-room/back-room operations and rapid response management. * Lead ...
Mdsap Auditor information
See salary details
$30.5K - $38.4K
4% of jobs
$38.4K - $46.3K
14% of jobs
$48.6K is the 25th percentile. Wages below this are outliers.
$46.3K - $54.2K
24% of jobs
The median wage is $60.8K / yr.
$54.2K - $62.1K
9% of jobs
$62.1K - $70K
7% of jobs
$70K - $78K
6% of jobs
$78K - $85.9K
6% of jobs
$92.3K is the 75th percentile. Wages above this are outliers.
$85.9K - $93.8K
4% of jobs
$93.8K - $101.7K
6% of jobs
$101.7K - $109.6K
6% of jobs
$109.6K - $117.5K
12% of jobs
$30.5K
$72.6K
$117.5K
How much do mdsap auditor jobs pay per year?
As of Jun 15, 2026, the average yearly pay for mdsap auditor in the United States is $72,633.00, according to ZipRecruiter salary data. Most workers in this role earn between $47,000.00 and $98,500.00 per year, depending on experience, location, and employer.
What are the key skills and qualifications needed to thrive as an MDSAP Auditor, and why are they important?
To thrive as an MDSAP Auditor, you need a solid background in quality management systems, regulatory compliance, and auditing principles, typically backed by a degree in science or engineering and relevant auditor certifications. Familiarity with ISO 13485, FDA regulations, Health Canada, and other global regulatory frameworks, as well as audit management software, is essential. Strong analytical thinking, attention to detail, and effective communication skills set top performers apart in this role. These skills ensure accurate, comprehensive audits that help medical device organizations maintain compliance and patient safety on a global scale.
What are some common challenges faced by MDSAP Auditors during multi-country audits?
MDSAP Auditors often encounter challenges such as navigating differing regulatory requirements across participating countries, coordinating communication among multinational client teams, and managing complex documentation in various languages. Additionally, balancing thoroughness with audit time constraints can be demanding, as auditors must ensure full compliance with standards while respecting client schedules. Collaboration with cross-functional teams and adaptability to evolving regulations are key to successfully overcoming these challenges.
What is the difference between Mdsap Auditor vs ISO 13485 Auditor?
| Aspect | Mdsap Auditor | ISO 13485 Auditor |
|---|---|---|
| Certifications | Requires MDSAP-specific training and certification | Requires ISO 13485 certification |
| Work Environment | Audits medical device manufacturers for MDSAP compliance | Audits medical device quality management systems for ISO 13485 |
| Industry Usage | Primarily in countries participating in MDSAP | Global, across industries requiring ISO 13485 |
The Mdsap Auditor and ISO 13485 Auditor roles share similarities in auditing medical device quality systems but differ mainly in scope and certification. Mdsap Auditors focus on compliance with MDSAP requirements, often in specific countries, while ISO 13485 Auditors assess adherence to international quality standards applicable worldwide. Both roles require specialized training and are vital in ensuring medical device safety and quality.
What are MDSAP Auditors?
MDSAP Auditors are professionals authorized to assess medical device manufacturers for compliance with the Medical Device Single Audit Program (MDSAP) requirements. They evaluate whether companies meet the regulatory standards of participating countries, such as the US, Canada, Australia, Brazil, and Japan, through a single comprehensive audit. Their role involves reviewing quality management systems, production processes, and documentation to ensure patient safety and regulatory adherence.
More about Mdsap Auditor jobs
What cities are hiring for Mdsap Auditor jobs? Cities with the most Mdsap Auditor job openings:
What states have the most Mdsap Auditor jobs? States with the most job openings for Mdsap Auditor jobs include:
What job categories do people searching Mdsap Auditor jobs look for? The top searched job categories for Mdsap Auditor jobs are:
- Medical Device Regulatory Compliance
- Medical Device Compliance
- Salaried Vp Engineering Medical Device
- Medical Devices Eu Mdr
- Complaint Management Medical Device
- Medical Device Development Engineer
- Locum Medical Device Design
- Contract Medical Device
- Overnight Complaint Handling Medical Device
- Senior Complaint Handling Medical Device
Japan medical device QMS 13485 auditor (relocation)
BSI Prof Serv EHS WestConcord, NC • On-site, Remote
Other
Posted 22 hours ago
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.
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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.