Introduction to GMED North America
GMED North America, a leading Certification Organization and distinguished Notified Body (CE0459), is seeking an experienced and skilled Medical Device Evaluator and Product Reviewer to join our team. As a subsidiary of GMED, we are authorized to act under European Regulation (EU) 2017/745 on medical devices and are committed to providing the best in Product Certification and Quality Management Services for medical device manufacturers worldwide. Our goal is to ensure the safety and effectiveness of medical devices, and we are looking for a dedicated professional to help us achieve this mission.
Job Overview
As a Medical Device Evaluator and Product Reviewer, you will play a critical role in our organization by conducting evaluations of medical devices and in-vitro diagnostics as part of the CE marking conformity assessment procedures. 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 provide comprehensive review reports that support or reject manufacturer applications for CE marking. Your work will have a direct impact on the safety and effectiveness of medical devices, and you will be an essential part of our team.
Key Responsibilities
- Conduct CE type and CE design dossier/product review evaluations in the framework of applicable European Directives and Regulations (CE) for different device classes and a wide range of medical devices.
- Coordinate with other product reviewers/evaluators, clinical experts, process experts, technical experts, and certification project managers to meet review timelines and ensure the consistency of information.
- Participate in standardization, technical, and/or regulatory workshops or speaking events to stay up-to-date with industry developments and share your expertise.
- 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 animate training sessions or technical days to share your knowledge and expertise with colleagues.
- Perform other duties and responsibilities as required or requested by management.
Essential Qualifications
To be successful in this role, you will need to have:
- A university or technical college degree or equivalent qualification in a relevant field, such as medicine, pharmacy, engineering, or other relevant sciences.
- At least 4 years of professional experience in the field of healthcare products or related activities, such as manufacturing, auditing, or research.
- At least 2 years of experience in the design, manufacture, testing, or use of medical devices or related technologies.
Preferred Qualifications
While not essential, the following qualifications are preferred:
- Experience working with medical devices or in-vitro diagnostics, particularly in the areas of CE marking and regulatory compliance.
- Knowledge of European Directives and Regulations (CE) and other relevant standards and regulations.
- Excellent communication and interpersonal skills, with the ability to work effectively in a team environment.
- Strong analytical and problem-solving skills, with attention to detail and ability to prioritize tasks.
Skills and Competencies
To be successful in this role, you will need to possess the following skills and competencies:
- Technical expertise: A strong understanding of medical devices and in-vitro diagnostics, including design, manufacture, testing, and use.
- Regulatory knowledge: Familiarity with European Directives and Regulations (CE) and other relevant standards and regulations.
- Communication skills: Excellent written and verbal communication skills, with the ability to effectively communicate complex technical information to stakeholders.
- Teamwork and collaboration: Ability to work effectively in a team environment, with a strong focus on collaboration and coordination with colleagues.
- Problem-solving and analytical skills: Strong analytical and problem-solving skills, with attention to detail and ability to prioritize tasks.
Career Growth Opportunities
At GMED North America, we are committed to providing our employees with opportunities for growth and development. As a Medical Device Evaluator and Product Reviewer, you will have the opportunity to work on a wide range of medical devices and in-vitro diagnostics, and to develop your expertise in regulatory compliance and CE marking. You will also have the opportunity to participate in training and development programs, and to take on additional responsibilities as you grow in your role.
Learning and Development Benefits
We offer a range of learning and development benefits, including:
- Training and development programs to help you develop your skills and expertise.
- Opportunities to participate in industry events and conferences.
- Access to a range of online resources and training materials.
Work Environment and Company Culture
At GMED North America, we are committed to creating a positive and supportive work environment that fosters collaboration, innovation, and growth. Our company culture is built on a set of core values, including:
- Commitment to clients and patients' safety: We are dedicated to ensuring the safety and effectiveness of medical devices.
- Expertise: We are committed to developing and maintaining the expertise of our employees.
- Reliability: We are reliable and trustworthy in our interactions with clients and stakeholders.
- Teamwork: We work collaboratively as a team to achieve our goals and objectives.
Diversity and Inclusion
We are an Equal Employment Opportunity Employer, committed to creating a diverse and inclusive work environment. We recruit, employ, train, compensate, and promote regardless of race, religion, sex, national origin, ethnicity, age, disability, pregnancy, political affiliation, sexual orientation, gender identity, color, marital status, veteran status, medical condition, and all the other characteristics that make us unique.
Compensation and Benefits
We offer a competitive salary and benefits package, including:
- Group-sponsored health, dental, and vision coverage.
- Flexible spending accounts.
- Short-term and long-term disability insurance.
- Company-paid life insurance.
- Competitive base salary and annual bonus based on company performance.
- 401K retirement program.
Work-Life Balance
We are committed to supporting our employees in achieving a healthy work-life balance. We offer a range of benefits and programs to support this, including:
- Telework and flexible working arrangements.
- Generous time off program.
- Paid holidays and bereavement leave.
- Paid parental leave.
- Commuter benefits program for public transportation.
- Internet stipend.
Conclusion
If you are a motivated and experienced medical device professional looking for a new challenge, we encourage you to apply for this exciting opportunity. As a Medical Device Evaluator and Product Reviewer at GMED North America, you will have the opportunity to work on a wide range of medical devices and in-vitro diagnostics, and to develop your expertise in regulatory compliance and CE marking. You will be part of a dynamic and supportive team, and will have the opportunity to contribute to the safety and effectiveness of medical devices. Don't miss out on this opportunity to join our team and make a difference in the lives of patients and healthcare professionals around the world.
How to Apply
To apply for this role, please submit your application through our website. We look forward to hearing from you and exploring how you can contribute to our team.
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