Job Overview:
We are seeking a highly skilled and experienced Medical Device Evaluator and Product Reviewer to join our team at GMED North America. As a leading Certification Organization and Notified Body, we are committed to ensuring the safety and efficacy of medical devices. In this role, you will play a critical part in evaluating medical devices and providing expert reviews to support the certification process.
Key Responsibilities:
- Conduct comprehensive evaluations of medical devices, including design dossiers and technical documentation, to determine compliance with relevant standards and regulations
- Collaborate with cross-functional teams, including clinical experts, process experts, and technical experts, to ensure thorough and accurate reviews
- Participate in standardization, technical, and regulatory workshops, and speaking events to stay up-to-date on industry developments and share expertise
- Provide regulatory monitoring and communication within the team, ensuring awareness of new requirements and updates in medical device expertise
- Develop and deliver training sessions and technical days to share knowledge and expertise with colleagues
Requirements:
- 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 field of healthcare products or related activities, with 2 years of experience in design, manufacture, testing, or use of medical devices or related technologies
- Strong understanding of medical device regulations, including European Directives and Regulations
- Excellent analytical, communication, and problem-solving skills
What We Offer:
At GMED North America, we offer a competitive benefits package, including:
- Group-sponsored health, dental, and vision coverage
- Flexible spending accounts and short-term and long-term disability insurance
- Company-paid life insurance and 401K retirement program
- Opportunities for growth and development within the organization
- Flexible working arrangements, including telework options and generous time off program
Our Culture:
We value diversity, inclusion, and a healthy work environment, and are committed to creating a unique culture that supports the well-being and success of our employees. Our values include:
- Commitment to clients and patients' safety
- Expertise and reliability
- Teamwork and collaboration
How to Apply:
If you are a motivated and experienced professional looking to join a dynamic team, please submit your application today. We look forward to hearing from you!
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