Medical Device Evaluator and Product Reviewer

Remote Full-time
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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