IVDR Product Reviewer

IVDR Product Reviewer

Classification: Exempt, Full-Time

Salary Grade/Level/Family/Range: Product Reviewers Range

Reports to: Assessment Dept Manager

Direct reports: None

Start date: December 1st, 2026

JOB DESCRIPTION

Summary/Objective:

As part of your mission as an evaluator/product reviewer, you will be responsible for carrying out evaluations as part of the CE marking conformity assessment procedures in the field of medical devices and/or IVD Medical Devices.

You will be responsible for reviewing the design dossiers/technical documentation independently or as a team of evaluators for a range of medical devices/IVDs with the goal of verifying whether the devices meet the requirements of the relevant standards/regulation. The deliverable will be comprehensive review reports which either support or reject the manufacturer's application for CE marking based on the evidence provided. Ultimately your work will determine whether a device has been demonstrated to be safe and effective, meets its intended use, and can be recommended for CE certification to the notified body.

Essential Functions:

Job Specific Competencies:

Supervisory Responsibility:

This position has no supervisory responsibilities.

Work Environment:

While performing the duties of this job, the employee regularly works at the client site(s), at home office and in an office setting.

Physical Demands:

While performing the duties of this job, the employee is regularly required to use hands and fingers to handle, feel, or operate objects, tools or controls, and reach with hands and arms. The employee is frequently required to stand, talk and hear.

Position Type/Expected Hours of Work:

This is a full-time exempt position. This means that you are expected to work at least 40 hours per week, or as many hours as you need to perform your duties.

Travel:

This position may require travel for business purposes.

Required Education and Experience:

Other Duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.