Product Reviewer

🕒 April 23

🦀 Maryland – Remote

🦀 Maryland – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

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GMED

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 1994

🏥 Healthcare

📋 Compliance

🤝 B2B

Healthcare • Compliance • B2B

GMED is an international notified body and certification body specializing in medical devices. GMED assesses conformity of medical devices and quality management systems (QMS) to enable manufacturers to place products on global markets, offering CE marking, QMS certification, MDSAP program support, device testing, and training. With over 30 years of experience and teams dedicated to Europe, Asia and North America, GMED covers a range of device types including implantable, custom-made, electromedical and in vitro diagnostic devices, and operates as part of the LNE group.

📋 Description

• 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

🎯 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

🏖️ Benefits

• 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 • work-life balance through the 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