Clinical Scientist

Remote • Posted 5 hours ago • Updated 5 hours ago
Contract Independent
Contract W2
Remote
Depends on Experience
Fitment

Dice Job Match Score™

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Job Details

Skills

  • Biomedicine
  • Clinical Research
  • Design Controls
  • ISO 9000
  • Medical Devices
  • Risk Management
  • Evaluation

Summary

Role: Clinical Scientist Design Controls Remediation

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

  • Advanced degree in biomedical sciences, clinical research, or related field; clinical research certification preferred.
  • Experience in medical device clinical science or clinical evaluation, including Design Input development and risk management.
  • In-depth knowledge of ISO 14155 and FDA clinical evidence requirements
  • Experience with clinical literature reviews, data analysis, and gap remediation in DHF projects
  • Strong scientific writing and cross-functional collaboration skills
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 10238807
  • Position Id: 8919151
  • Posted 5 hours ago
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