Job Description
Job Title: Clinical Scientist - Design Controls Remediation
Location: Remote (W2 only)
Duration: 09+ Months (Can extend up to 24 months)
Role Summary
The Clinical Scientist will provide scientific and clinical expertise to support gap assessments and remediation of Design Inputs (use needs / clinical requirements), Risk Management (clinical hazards), and V&V strategies, ensuring the medical device’s clinical performance claims are substantiated and compliant.
- Responsibilities
- Perform gap analyses of clinical evidence supporting Design Inputs, risk management files, and clinical evaluation plans/reports
- Contribute to the development or updating of clinical risk-benefit analyses and post-market surveillance plans
- Support design of V&V protocols that incorporate clinical endpoints or simulated use testing
- Collaborate with Clinical and Pre-Clinical SMEs to align non-clinical and clinical data with design control elements
- Prepare technical summaries and justifications for regulatory submissions related to clinical aspects of the DHF Qualifications
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