Clinical Scientist - Medical Device

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