Product Reviewer

G-MED NORTH AMERICA, Inc.

3h•Hybrid

About The Position

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. This involves reviewing design dossiers and technical documentation independently or as part of a team to verify that medical devices meet the requirements of relevant standards and regulations. Your work will culminate in comprehensive review reports that either support or reject a manufacturer's application for CE marking, ultimately determining if a device is safe, effective, meets its intended use, and can be recommended for CE certification to the notified body.

Requirements

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.

Responsibilities

Conduct CE type and CE design dossier/product review evaluations in the framework of the applicable European Directives and Regulations (CE) for different device classes and for a wide range of medical devices depending on the area of expertise.
Coordinate with other product reviewers/evaluators, clinical experts, 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.
Performs other duties and responsibilities as required or requested or delegated.

Benefits

full and competitive benefits package including group-sponsored health, dental, and vision coverage
flexible spending accounts
short-term and long-term disability
company-paid life insurance
competitive base salary
annual bonus based on company performance
401K retirement program
option to telework
flexible working arrangements
generous time off program
paid holidays
paid bereavement leave
paid parental leave
commuter benefits program for public transportation
internet stipend
growth opportunities within the organization