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Senior Manager Clinical Safety Monitor

Location California, USA
Sector
Job Type Permanent
Salary Negotiable
Published 17 days ago
Start Date ASAP
Contact Reece Mitellas
Job Ref HQ7488_1530838757

Job Description

  • Works with Product Development teams on Risk Management activities to determine hazardous situations and severity levels using relevant clinical information.
  • Creates and maintains Clinical Evaluation Reports (CER)
  • Supplies a medical judgment when needed to determine adverse event reportability.
  • Supports maintenance of technical files, MDD certifications, and declarations of conformity in support of EU product registrations/CE mark.
  • Assists the Regulatory team with Field Action decisions by providing clinical information regarding health hazards.
  • Define possible hazardous situations and creates a Health Hazard Evaluation (HHE) reports.
  • Create post-market clinical safety and risk management programs.
  • Provides input and review to regulatory or clinical documents as appropriate
  • Ensure key safety documents are of high safety and scientific quality.

Qualifications

  • Required Master's degree, preferably in life sciences or Biomedical Engineering, or a strong clinical research experience coupled with direct experience in a related medical device space.
  • Clinical background
  • Experience in clinical affairs, preferably within the medical or health care industry
  • Experience in clinical safety, clinical research, and vigilance.
  • Familiar with the development and manufacture of medical devices including Risk Management.
  • Proficient with literature searches and researching clinical information. Proven ability to create Clinical Evaluation Reports.
  • Demonstrated in-depth knowledge of assessment of clinical device risks and benefits, and safety assessment of clinical devices both on the market and in development and global safety regulations.

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