Medical Device Clinical Specialist
1 week ago
GMED NA is seeking a highly skilled Medical Device Clinical Specialist to join our team. As a key member of our team, you will be responsible for assessing clinical studies of various medical devices, ensuring compliance with European Medical Devices Directives and Regulations, and other applicable regulatory systems.
Key Responsibilities:- Perform thorough assessments of manufacturer's clinical evaluation reports, including equivalence rationales and risk assessments, appropriateness of clinical claims, and adequacy of endpoints and follow-up data.
- Develop and maintain expertise in present and pending regulatory requirements, standards, and GMED NA America service capabilities.
- Provide internal and external training in areas of expertise, including customer service and project management.
- Collaborate with cross-functional teams to ensure seamless delivery of services within required timescales.
- Doctor in Medicine
- Minimum four years in healthcare services or related sectors, including experience in usage, development, or testing/evaluation of medical devices or clinical study or clinical evaluation of such devices.
- Excellent knowledge of spoken and written English language.
- French language knowledge is a plus.
- Competitive base salary and annual bonus based on company performance
- Full and competitive benefits package, including group-sponsored health, dental, and vision coverage
- Flexible working arrangements, including telework options
- Opportunities for growth and professional development within the organization
GMED North America is an Equal Employment Opportunity Employer, committed to a diverse, inclusive, and healthy work environment with a unique culture. We recognize that our success is driven by the expertise and commitment of our team, and we are focused on creating an environment where top professionals can thrive.
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