Job Description
Riverpoint Medical is seeking a contract Clinical (Medical) Reviewer to contribute and review regulatory submissions. This is not a fulltime role and work is dependent on the amount and timing of regulatory submissions. The require signature on the Independent Contractor Agreement from Riverpoint.
Duties and Responsibilities:
• Review and approve regulatory documentation that requires clinician (MD, DO, NP, PA, etc.) input.
• Contribute to projects that require clinician input regarding standard of care and patient outcomes.
• Work with the regulatory team to learn internal and regulatory body requirements for clinician reviews.
• Review and provide signature on Clinical Evaluation Reports for EU submissions. Review medical information for accuracy, review benefit-risk profile, provide feedback from a medical professional standpoint. Provide input to other associated documentation such as instructions for use, surgical technique guides, and others.
Qualifications:
• Orthopedic/clinical experience treating surgical patients with sports medicine/soft tissue injuries.
• Past exposure/approval of regulatory documentation or medical device design team experience.
• Knowledge of the standard of care for sports medicine and orthopedic injuries.
• Ability to create technical documentation for customer regulatory submissions.
• Attention to detail to review complex regulatory documents.
• Past experience reviewing Clinical Evaluation Reports and clinical research experience a plus.
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