Clinical Evaluation Specialist
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Job Summary
Leading the development and maintenance of clinical evaluation documentation, the full-time remote Clinical Evaluation Specialist will manage the preparation of Clinical Evaluation Reports, conduct systematic literature reviews, and analyze clinical data to support regulatory submissions for medical devices.
Key responsibilities
- Lead the preparation and updates of Clinical Evaluation Reports, Clinical Evaluation Plans, and related documentation for regulatory compliance
- Design literature search strategies and conduct systematic reviews to evaluate published clinical evidence
- Analyze clinical and marketing data to assess device safety, performance, and benefit-risk ratios
Required qualifications
- Bachelor's degree in Life Sciences, Engineering, or a related field
- Minimum 4 years of experience in Regulatory Affairs, Clinical Affairs, or Clinical Evaluation
- Prior experience in the medical device industry
- Experience developing clinical evaluation documentation for medical devices
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