Staff Clinical Evaluation Specialist
Core
Develop clinical evidence strategies and documentation to validate device safety and performance for regulatory submissions.
Role type
Staff Clinical Evaluation Specialist
Builds
Clinical evaluation reports (CERs), safety risk analyses, and regulatory submissions (510(k), PMA)
Domain
Medical devices / Regulatory Affairs
Required skills
Clinical evidence strategy, systematic literature reviews, benefit-risk assessment, regulatory compliance, safety risk analysis, post-market surveillance, clinical documentation authoring, user needs analysis, adverse event review, corrective and preventive action (CAPA)
Preferred skills
Medical writing, academic or clinical research experience, mentoring, project management, MS Office proficiency
Technologies
None stated
Responsibilities
Drive clinical evidence strategy alignment with marketing and regulatory plans; prepare clinical documentation for regulatory submissions; design literature search strategies and perform systematic reviews; formulate benefit-risk profiles; review peer-authored clinical documentation; provide input to pre-IDE and 510(k) applications; participate in safety risk analysis; support human factors team in use scenario development; review product complaints for adverse events; contribute to CAPA activities and operating instructions; support clinical study protocols and marketing materials.
Seniority
Senior, hands-on IC