CE Medical Device Evaluator & Reviewer

GMED

United States

Remote

USD 90,000 - 130,000

Full time

14 days+

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Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401K retirement plan

Annual bonus

Telework option

Job summary

GMED North America, the US subsidiary of GMED, is seeking an Evaluator/Reviewer to perform CE marking conformity assessments across medical devices. You will review design dossiers and technical documentation to verify compliance with applicable EU directives and regulations, delivering comprehensive reports to support or reject CE certification.

The role requires coordinating with internal experts, leading training sessions, and staying updated on regulatory changes while contributing to a

Qualifications

University degree in medicine, pharmacy, engineering or other relevant sciences.
4 years of professional experience in healthcare products or related activities.
2 years shall be in the design, manufacture, testing, or use of the device or technology to be assessed.

Responsibilities

Conduct CE type and CE design dossier/product review evaluations for different device classes.
Coordinate with reviewers, clinical and process experts to meet review timelines and ensure report quality.
Participate in standardization, technical, and regulatory workshops or events.
Ensure regulatory monitoring and communication within the team on new requirements.
Provide pedagogical responsibility and lead training sessions or technical days.
Performs other duties as required or delegated.