ZipRecruiter

Log In

1

Notified Body Medical Device Reviewer Jobs (NOW HIRING)

Delcath Systems Inc

Quality System Manager

Queensbury, NY · On-site

$120K - $140K/yr

Lead Regulatory/Notified Body audits at the Queensbury site and provides support for Regulatory ... Monitor, review and interpret new or revised medical device regulatory requirements and proactively ...

AngioSafe

Medical Device R&D Engineer

San Jose, CA · On-site

$115K - $175K/yr

Minimum 5 years of medical device R&D experience * Hands-on catheter prototyping and testing ... Experience supporting FDA and/or Notified Body submissions * Experience using cloud-based document ...

AngioSafe

Medical Device R&D Engineer

San Jose, CA · On-site

$115K - $175K/yr

Minimum 5 years of medical device R&D experience * Hands-on catheter prototyping and testing ... Experience supporting FDA and/or Notified Body submissions * Experience using cloud-based document ...

Intertek

Coordinator, Medical Program

Boxborough, MA · Remote

Experience working for a medical device, pharma, cosmetics, and/or dietary supplement company. * Experience working for a registrar/AO/Notified Body. Intertek: Total Quality. Assured. Intertek is a ...

Heartflow

Senior Device Quality Engineer

San Francisco, CA · Hybrid

$160K - $180K/yr

Support the organization during internal and external audits (e.g., FDA, Notified Body, MDSAP) as a ... medical device industry. * Certifications (Preferred): ASQ Certified Quality Engineer (CQE ...

Scarlet

Lead Auditor - Contractor role

You will work flexibly, supporting audit delivery as part of Scarlet's notified body activities. Your responsibilities * Conduct remote audits of medical device manufacturers' Quality Management ...

Getinge

Principal Quality Internal Auditor

Wayne, NJ · On-site

$155K - $165K/yr

Review and approve audit reports, findings, and CAPA plans to ensure timely and effective ... in the medical device industry, including direct audit leadership at FDA or Notified Bodies ...

Getinge

Principal Quality Internal Auditor

Wayne, NJ · On-site

$155K - $165K/yr

Review and approve audit reports, findings, and CAPA plans to ensure timely and effective ... in the medical device industry, including direct audit leadership at FDA or Notified Bodies ...

CEDENT

Regulatory Affairs Specialist

Bedford, MA

... the Notified Body. * Support submission and maintenance of product registrations in markets ... Experience in regulatory submissions to medical device regulatory bodies a plus; e.g., FDA, Health ...

next page

Showing results 1-20

All JobsNotified Body Medical Device Reviewer Jobs

Notified Body Medical Device Reviewer information

See salary details

$11

$42

$100

How much do notified body medical device reviewer jobs pay per hour?

As of Jun 8, 2026, the average hourly pay for notified body medical device reviewer in the United States is $42.06, according to ZipRecruiter salary data. Most workers in this role earn between $22.84 and $54.09 per hour, depending on experience, location, and employer.

What is a Notified Body Medical Device Reviewer?

A Notified Body Medical Device Reviewer is a professional who evaluates medical devices to ensure they meet the regulatory requirements for safety and performance before they can be marketed in the European Union. They work for organizations designated as 'Notified Bodies' under EU medical device regulations, such as the Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR). Their responsibilities include reviewing technical documentation, assessing clinical evidence, and auditing manufacturers' quality management systems. The reviewer's findings determine whether a device receives CE marking, allowing it to be sold in the EU. This role is crucial for public health and patient safety.

What is the difference between Notified Body Medical Device Reviewer vs Medical Device Quality Assurance Specialist?

AspectNotified Body Medical Device ReviewerMedical Device Quality Assurance Specialist
CredentialsRegulatory certifications, medical device knowledgeQuality management system certifications, ISO standards
Work EnvironmentRegulatory agencies, notified bodies, compliance reviewsManufacturers, quality departments, audit environments
Employer & Industry UsageRegulatory bodies, notified bodies, medical device industryMedical device companies, manufacturing, quality assurance

While both roles focus on medical device compliance, the Notified Body Medical Device Reviewer primarily evaluates device conformity for regulatory approval, whereas the Medical Device Quality Assurance Specialist ensures ongoing quality standards within manufacturing processes.

What are the key skills and qualifications needed to thrive as a Notified Body Medical Device Reviewer, and why are they important?

To thrive as a Notified Body Medical Device Reviewer, you generally need a strong background in biomedical engineering, life sciences, or a related field, paired with experience in regulatory compliance and quality management systems. Familiarity with ISO 13485, EU MDR/IVDR regulations, and auditing tools or systems is essential, along with relevant certifications such as Lead Auditor qualifications. Critical thinking, attention to detail, and effective communication are crucial for evaluating technical documentation and interacting with manufacturers. These competencies ensure thorough, accurate conformity assessments that uphold patient safety and regulatory compliance across the medical device industry.

What are some common challenges faced by a Notified Body Medical Device Reviewer when assessing technical documentation?

A common challenge for Notified Body Medical Device Reviewers is evaluating the completeness and clarity of manufacturers' technical documentation, which can vary significantly in quality and detail. Reviewers must ensure that all information complies with relevant regulations such as the EU Medical Device Regulation (MDR), and that clinical evaluation evidence is robust and up to date. This role often requires balancing thoroughness with tight deadlines, while collaborating closely with both internal experts and external stakeholders to resolve ambiguities and ensure regulatory compliance.
Infographic showing various Notified Body Medical Device Reviewer job openings in the United States as of May 2026, with employment types broken down into 100% Full Time. Highlights an 100% In-person job distribution, with an average salary of $87,476 per year, or $42.1 per hour.

Regulatory & Quality Systems Consultant_Medical Devices

Volto USA

Austin, TX • On-site

Contractor

Posted 24 days ago

Job description

Key Responsibilities:
•       Plan, scope, and lead comprehensive mock audits to assess readiness for an upcoming BSI notified body audit.
•       Evaluate the medical device manufacturer’s Quality Management System (QMS) against ISO 13485:2016 and the EU MDR 2017/745.
•       Conduct rigorous onsite or virtual stress-testing of core QMS processes:
o       Management Responsibility & Resource Management
o       Design and Development / Technical Documentation Files
o       Production and Service Provision (Cleanroom, Sterilization, Validation)
o       CAPA, Complaint Handling, and Post-Market Surveillance (PMS)
•       Review Technical Files and Design History Files (DHF) to ensure alignment with BSI expectations.
•       Prepare detailed mock audit reports, classifying findings into Major and Minor nonconformances using Notified Body criteria.
•       Provide a definitive gap analysis report outlining critical vulnerabilities and immediate remediation strategies.
•       Debrief leadership and process owners on audit outcomes, providing actionable guidance on how to interface with BSI auditors.
•       Assess the readiness of subject matter experts (SMEs) through simulated front-room/back-room interview dynamics.
Required Qualifications:
•       Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline.
•       Minimum 8 years of experience in the Medical Device industry, specifically in Quality Assurance or Regulatory Affairs.
•       Certified ISO 13485 Lead Auditor (IRCA, Exemplar Global, or equivalent).
•       Proven track record of preparing medical device manufacturers for successful Notified Body audits, specifically with BSI.
•       Deep, current knowledge of ISO 13485:2016, ISO 14971 (Risk Management), and European medical device regulations.
•       Strong analytical, interviewing, and technical report-writing skills.
•       Ability to deliver objective, critical feedback constructively under tight preparation timelines.
Preferred Qualifications:
•       Former BSI Lead Auditor experience is highly preferred.
•       Hands-on experience managing a front-room/back-room during a live BSI QMS audit.
•       Experience auditing the specific device risk classification and technology relevant to our product portfolio.
•       Familiarity with MDSAP requirements.
Key Competencies:
•       BSI Audit Readiness & Notified Body Interface
•       Rigorous Gap Analysis & Nonconformance Classification
•       Risk-Based Auditing & Technical File Evaluation
•       SME Coaching & Interview Preparation
•       Objective, High-Pressure Stakeholder Communication