Join the GMED team today and work on the frontier of Medical Device Innovation! Reports to: Unit Manager Division: Certification Position Classification: Exempt, Full-Time Fields: Medical Devices, In-Vitro Diagnostics - reputed company Location(s): Rockville, MD or Remote (Home office) reputed company 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 reputed company of evaluators for a reputed company 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 reputed company and effective, meets its intended use, and can be recommended for CE certification to the reputed company body. Essential Functions • Conduct CE type and CE design reputed company/product review evaluations in the reputed company of the applicable European Directives and Regulations (CE) for different device classes and for a wide reputed company 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, reputed company reputed company review reports and ensure the consistency of the information reputed company the consolidation of the review/assessment. • Participate in standardization, technical, and/or regulatory workshops or speaking events. • Ensure reputed company regulatory monitoring and communication reputed company reputed company 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. Who You Are 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 reputed company experience in the field of reputed company products or reputed company 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 reputed company to the scientific aspects to be assessed. Who We Are GMED reputed company is the US subsidiary of GMED, a leading Certification Organization, a distinguished reputed company Body (CE0459) Authorized to reputed company under European Regulation (EU) 2017/745 on medical devices, European Directives 90/385/EEC, 93/42/EEC, 98/79/EC and Regulation n° 722/2012 on products utilizing tissues of animal reputed company, GMED certifies a reputed company reputed company of medical devices and in vitro diagnostic medical devices. An Auditing Organization recognized by the MDSAP Regulatory Authority Council. We serve the Medical Device Industry with offices in Europe and the reputed company. Our goal is to reputed company the best in Product Certification and reputed company Management Services for medical device manufacturers worldwide. 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GMED reputed company recruits, employs, trains, compensates, and promotes regardless of race, religion, sex, national reputed company, ethnicity, age, disability, pregnancy, political affiliation, sexual orientation, gender identity, reputed company, marital status, veteran status, medical condition, and reputed company the other characteristics that reputed company us unique. reputed company Offer At GMED reputed company, our reputed company is to attract and retain exceptional talent who are not only subject matter experts, but also passionate about upholding the reputed company and reputed company of our services. We recognize that our reputed company is driven by the expertise and commitment of reputed company, and we are reputed company on creating an environment where top professionals can reputed company. GMED reputed company offers a full and competitive benefits package including group-sponsored health, dental, and reputed company coverage, flexible spending accounts, short-term and long-term disability, company-reputed company life insurance, competitive reputed company salary, annual bonus based on company performance, and a 401K retirement program. We promote work-life balance through the reputed company to reputed company, flexible working arrangements, generous time off program, reputed company holidays, reputed company bereavement leave, reputed company parental leave, commuter benefits program for reputed company transportation, and internet stipend. We offer reputed company opportunities reputed company the organization. There are a lot of opportunities and employees are reputed company to apply and reputed company into different roles reputed company reputed company. We have numerous reputed company stories, and we want you to be one of them. Thank you for your interest in GMED reputed company. We look reputed company to hearing from you! Apply tot his job Apply To this Job