Founded in 1989, Natus Medical Incorporated is a leading manufacturer of medical devices and software and a service provider for the Newborn Care, Neurology, Sleep, Hearing and Balance markets. Natus products are used in hospitals, clinics and laboratories worldwide. Our mission is to improve outcomes and patient care in target markets through innovative screening, diagnostic and treatment solutions.
The Clinical Safety Monitor works with Engineering, Quality and Regulatory and provides medical judgements in areas pertaining to Field Actions, Adverse EventReporting, Risk Management and Clinical EvaluationReports. Participates in device evaluations for the worldwide market.
This position you will:
- Works with Product Development teams on Risk Management activities to determine hazardous situations and severity levels using relevant clinical information.
- Creates and maintains Clinical EvaluationReports (CER) to meet MEDDEV Rev 4 requirements.
- Supplies a medical judgement when needed to determine adverse eventreportability.
- 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.
- Collaborates with cross functional teams on activities related to managing the safety of products.
- Investigates product non-conformances to define possible hazardous situations and creates Health Hazard Evaluation (HHE) reports.
- Participates in post-market clinical safety and risk management programs.
- Provides input and review to regulatory or clinical documents as appropriate, to ensure these key safety documents are of high safety and scientific quality.
- Stay up-to-date and follow all Quality Management System procedures related to this job, which can affect the quality of products or services provided to our customers.
- Supports internal/external audits and regulatory inspections.
- Participates on other special clinical projects as required.
- Required Master’s degree, preferably in life sciences or Biomedical Engineering, or BS degree with 10 years of clinical research experience coupled with direct experience in a related medical device space.
- Ideal candidate would have a strong "clinical" background as an Medical Doctor or Nurse Practitioner
- Minimum of eight years’ experience in clinical affairs, preferably within the medical or health care industry within the newborn and or pediatric population being a very strong preference.
- 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 EvaluationReports.
- 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.