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
Join the GMED NA team today and work on the frontier of Medical Device Innovation!
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.
You 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 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.
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 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.
- Ability to meet deadlines
- Confidentiality and impartiality
- English language proficient
- Reliability and accountability with good organizational skills
- Manage competing priorities
- Ability to work in a team
- Critical reasoning
- Excellent verbal and written communication/presentation ability
- Ability to draw up demonstrative records and reports
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 parts of the World.
- Commitment to Clients and Patients’ safety
- Team Work
What We Offer
We offer an excellent benefits package including group-sponsored health, dental and vision coverage, short-term and long-term disability, a company-matched 401k plan, 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 of your transcripts together with your resume and your cover letter.
We look forward to hearing from you!