[Hiring] Product Reviewer @G-MED NORTH AMERICA, Inc.

Role Description

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.

You will be responsible for reviewing the design dossiers / technical documentation independently or as a team of evaluators for a range of medical devices 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 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.

Qualifications

• 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.

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 and flexible working arrangements.
• Generous time off program, paid holidays, paid bereavement leave, and paid parental leave.
• Commuter benefits program for public transportation and internet stipend.
• Growth opportunities within the organization.