Join the GMED team today and work on the frontier of Medical Device Innovation!
Location(s): North Bethesda, MD
Contract Type: Perm Full-Time
Fields: Medical Device, In Vitro Diagnostics – Healthcare
The European Union recently published a new set of Regulations for the medical device sector. These new Regulations reinforce the pre-requisites and on-going pathway to evaluate Medical Device technologies. The Evaluator/Product Reviewer will carry out evaluations under the CE marking conformity assessment procedures for a variety of medical devices. He/she will be responsible for reviewing entire Design Dossiers /Technical Documentations independently or portions of it, together with a team of evaluators, to verify that they answer to the requirements of the relevant and applicable standards/regulations.
The deliverable expected will be comprehensive and detailed review report for each file, which either support or reject the manufacturer’ application for the CE marking of its product(s) based on the evidence he would have provided in the file(s). Ultimately, the Evaluator/Product Reviewer’ work is to determine if a manufacturer was able to demonstrate that its medical device is safe and effective, and performs according to its intended use and can be a recommended for CE certification by GMED, the Notified Body. This position will report directly to the Certification Department Director.
• Conduct CE type and CE design dossier / product review evaluations in the framework of the applicable European Medical Device Directives and Regulations (MDR 2017/745 – IVDR 2017/746) for a variety of medical devices and depending on their classification, their dedicated area of treatment(s) and according to the expertise required.
• Coordinate with other product reviewer(s)/evaluator(s), clinical expert(s), process expert(s), technical expert(s) and the certification project manager(s), to meet the review timelines defined for the project, provide quality review reporting(s) and ensure that consistency of the information via the consolidation of the review/assessment.
• Participate in standardization, technical and/or regulatory workshop(s), working group(s) or speaker’ event(s).
• Ensures active monitoring and communication on new or evolution(s) of regulatory requirement(s) identified within your specific area(s) of medical device expertise.
• Endorses pedagogical approach to disseminate and animate training session(s) or technical/regulatory day(s).
• Performs other duties and responsibilities as required, 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 professional experience in healthcare, dealing with products or related activities, such as manufacturing, auditing or research and development ( R&D); 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
• Working in a fast-paced environment.
• Proficient in Word, Excel, Power Point & Outlook.
• Proficient in English.
• Excellent verbal and written communication / presentation ability.
• Ability to draw up demonstrative record(s) and report(s)
• Thorough and concise.
• Meticulous and detail oriented.
• Exceptional organizational skills.
• Ability to follow direction, manage multiple projects and meet challenging deadlines.
• Self-starter who works well independently but also in various group settings.
• Team player, reliable and focused on core missions.
• Impartial and discreet when managing confidential information.
• Ability to create an environment that promotes trust when interacting with the team member(s) throughout the project(s).
Who We Are
GMED North America is the US subsidiary of GMED, a leading Certification Organization, a distinguished Notified Body (CE0459) whose scope covers all of the existing European Medical Device Directives (90/385/EEC, 93/42/EEC and 98/79/EC) and an Auditing Organization Recognized by the MDSAP Regulatory Authority Council. We serve the Medical Device Industry with offices in Europe and the United States. Our goal is to provide the best in Product Certification and Quality Management Services for Medical Device Manufacturers worldwide. At GMED North America, we strive to the highest standards of professionalism, competency, work ethic, and customer service. All our employees are an important part of this process because their work directly influences GMED North America’s reputation.
Aside from our expertise and due diligence, we pride ourselves in our diverse workforces, with employees from different backgrounds and culture. Our Values:
• Commitment to Clients and Patients’ safety
• Team Work
What We Offer
We offer an excellent benefits package including a group-sponsored health, dental and vision coverage, short-term and long-term disability, a company-matched 401k plan, a company paid life insurance, paid holidays and time off program providing our employees with great work-life balance. We offer growth opportunities within the organization. There are a lot of opportunities and employees are able to apply and move into different roles within the company. We have numerous success stories, and we want you to be one of them.
GMED North America is an Equal Employment Opportunity Employer, committed to a diverse, inclusive, and healthy work environment with a unique culture.
You are strongly encouraged to submit a copy your transcripts together with your resume and your application letter.
We look forward to hearing from you!