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- 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.
- 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.