Join the GMED Team: Shaping the Future of Medical Device Innovation
GMED North America, a leading Certification Organization and distinguished Notified Body, is seeking an experienced Medical Device Evaluator and Product Reviewer to join our team. As a key player in the Certification division, you will be responsible for conducting evaluations and reviewing technical documentation for a range of medical devices to ensure compliance with relevant European Directives and Regulations.
About Us
GMED North America is the US subsidiary of GMED, a renowned Certification Organization authorized to act under European Regulation (EU) 2017/745 on medical devices. We serve the Medical Device Industry with offices in Europe and the United States, providing top-notch Product Certification and Quality Management Services for medical device manufacturers worldwide. Our commitment to professionalism, competency, work ethic, and customer service is unwavering, and we pride ourselves on our diverse workforce and inclusive culture.
Job Overview
As an Evaluator/Product Reviewer, you will play a critical role in the CE marking conformity assessment procedures for medical devices. Your primary responsibility will be to review design dossiers and technical documentation to verify whether medical devices meet the requirements of relevant standards and regulations. You will work independently or as part of a team to produce comprehensive review reports that support or reject manufacturers' applications for CE marking.
Key Responsibilities
- Conduct CE type and CE design dossier/product review evaluations in accordance with applicable European Directives and Regulations (CE) for various device classes and medical devices.
- Coordinate with other product reviewers, clinical experts, technical experts, and certification project managers to meet review timelines and ensure the quality and consistency of review reports.
- Participate in standardization, technical, and regulatory workshops or speaking events to stay updated on industry developments.
- Monitor and communicate new regulatory requirements within the team, leveraging your expertise in specific areas of medical devices.
- Take on a pedagogical role by leading training sessions or technical days to enhance team knowledge and capabilities.
- Perform other duties and responsibilities as required or delegated.
Who You Are
Essential Qualifications
- A university or technical college degree in a relevant field such as medicine, pharmacy, engineering, or other relevant sciences.
- At least 4 years of professional experience in the healthcare products industry or related activities, including manufacturing, auditing, or research.
- A minimum of 2 years of experience in the design, manufacture, testing, or use of medical devices or related technologies.
Preferred Qualifications
- Experience working with medical devices, in-vitro diagnostics, or related healthcare products.
- Knowledge of European Directives and Regulations (CE) governing medical devices.
- Strong analytical and problem-solving skills.
- Excellent communication and teamwork abilities.
Skills and Competencies
To succeed in this role, you will need to possess a combination of technical expertise, analytical skills, and soft skills. Key competencies include:
- Strong understanding of medical device regulations and standards.
- Excellent analytical and critical thinking skills.
- Effective communication and interpersonal skills.
- Ability to work independently and as part of a team.
- Strong organizational and time management skills.
Career Growth and Learning Benefits
At GMED North America, we are committed to fostering a culture of continuous learning and professional growth. As an Evaluator/Product Reviewer, you will have opportunities to:
- Develop your technical expertise in medical device regulations and standards.
- Enhance your analytical and problem-solving skills through complex review projects.
- Expand your network through participation in industry events and workshops.
- Take on leadership roles or mentoring responsibilities within the team.
Work Environment and Company Culture
GMED North America offers a dynamic and inclusive work environment that values diversity, equity, and inclusion. As a remote worker, you will be part of a distributed team that collaborates through digital channels. We prioritize work-life balance and offer flexible working arrangements to support your well-being.
Compensation and Benefits
We offer a competitive salary and a comprehensive benefits package, including:
- Group-sponsored health, dental, and vision coverage.
- Flexible spending accounts and retirement savings plans.
- Short-term and long-term disability insurance.
- Company-paid life insurance.
- Annual bonus based on company performance.
- Generous time off program, paid holidays, and parental leave.
- Commuter benefits and internet stipend.
Join Our Team
If you are a motivated and experienced professional looking to make a difference in the medical device industry, we encourage you to apply for this exciting opportunity. At GMED North America, we are passionate about upholding the highest standards of professionalism and excellence, and we are seeking talented individuals to join our team.
Don't miss out on this chance to shape the future of medical device innovation. Apply now and become part of our dynamic team!
Apply Now