Staff Clinical Evaluation Specialist

Required

• Bachelor’s degree required. Preferred to be in Life Sciences, Engineering, or a related field.
• Minimum 4 years of experience in Regulatory Affairs, Clinical Affairs, Clinical Evaluation, or a related function supporting regulatory or clinical evidence activities.
• Prior experience within the medical device industry.
• Experience developing clinical evaluation documentation for medical devices, including Clinical Evaluation Reports, Clinical Evaluation Plans, Summaries of Safety and Clinical Performance, or post-market clinical follow-up documentation.

• Lead the preparation and periodic updates of Clinical Evaluation Reports (CERs), Clinical Evaluation Plans (CEPs), Summary of Safety and Clinical Performance documents (SSCPs), Post-Market Clinical Follow-up Plans (PMCFPs), and Post-Market Clinical Follow-up Reports (PMCFRs) to support regulatory submissions and ongoing compliance.
• Design compliant, sustainable literature search strategies and conduct systematic literature reviews to identify, evaluate, and summarize published clinical evidence and current scientific and medical practice.
• Analyze clinical, post-market surveillance, preclinical, and marketing data using quantitative and qualitative methods to evaluate device safety, performance, and benefit-risk.
• Lead clinical evaluation projects and establish clinical evidence strategies throughout new product development, aligning clinical evidence with regulatory, clinical research, preclinical testing, marketing, and product claims strategies.
• Evaluate clinical evidence against current U.S., European, and Australian regulatory requirements and collaborate with medical experts and cross-functional stakeholders to develop scientific conclusions on device safety and performance.
• Identify evidence gaps and residual risks and develop post-market clinical follow-up activities with Clinical Research to address unanswered clinical questions.
• Translate clinical data and scientific findings into peer-reviewed publications, white papers, clinical summaries, posters, presentations, and other materials supporting cross-functional business needs.