IVDR Product Reviewer

G-MED NORTH AMERICA, Inc.; United States; Remote; USD 90,000 - 130,000; Full time

Job summary

G-MED NORTH AMERICA, Inc. is seeking an IVDR Product Reviewer for a full-time remote role based in the United States. The position involves evaluating CE marking conformity for medical devices and IVDs, reviewing dossiers, and producing reports to determine safety, effectiveness, and suitability for CE certification.

The role requires a strong background in healthcare products, attention to detail, and the ability to collaborate with clinical and regulatory experts to meet project timelines.

Qualifications

• University or technical degree in medicine, pharmacy, engineering or relevant sciences.
• 4+ years in healthcare products or related activities (manufacturing, auditing, research).
• At least 2 years in design, manufacture, testing, or use of the device/technology being assessed.

Responsibilities

• Perform CE type and dossier reviews for various device classes under applicable regulations.
• Coordinate with reviewers, clinical experts, and project managers to meet timelines.
• Present findings in comprehensive review reports to support or reject CE marking.

Skills

Detail-oriented

Deadlines

Confidentiality

Organizational skills

Multitasking

Teamwork

Critical thinking

Verbal & written comms

Documentation/reporting

Education

University or technical degree in relevant field

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

IVDR Product Reviewer

Full Time Remote, US

IVDR Product Reviewer

Classification: Exempt, Full-Time

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

Reports to: Assessment Dept Manager

Direct reports: None

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:

• Conduct CE type and CE design dossier/product review evaluations in the framework of the applicable European Regulations (CE) for different device classes and for a wide range of medical devices and IVDs depending on the area of expertise.
• Coordinate with other product reviewers/evaluators, clinical experts, performance evaluators, process experts, technical experts, and the certification project managers to meet the review timelines, provide quality review reports and ensure the consistency of the information via the consolidation of the review/assessment.
• Participate in standardization, technical, and/or regulatory workshops or speaking events.
• Ensure active regulatory monitoring and communication within the team of new requirements identified in your specific areas of medical device expertise.
• Have pedagogical responsibility and the animation of training sessions or technical days.
• Perform other duties and responsibilities as required or requested or delegated.

Job Specific Competencies:

• Detail-oriented
• Ability to meet deadlines
• Confidentiality and impartiality
• Reliability and accountability with good organizational skills
• Manage competing priorities
• Ability to work in a team
• Critical reasoning
• Excellent verbal and written communication/presentation ability
• Ability to draw up demonstrative records and reports

Supervisory Responsibility:

This position has no supervisory responsibilities.

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:

• Successful completion of a university or a technical college degree or equivalent qualification in relevant studies, e.g. medicine, pharmacy engineering or other relevant sciences;
• 4 years of professional experience in the field of healthcare products or related activities, such as in manufacturing, auditing or research;
• Of which 2 years shall be in the design, manufacture, testing, or use of the device or technology to be assessed or related to the scientific aspects to be assessed.

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.