Product Incident Risk Management Expert

Product Incident Risk Management Expert

Requirements

• Bachelors or master’s in biomedical engineering, regulatory affairs, public health or microbiology, biochemistry specifically for IVDs, preferred.
• 3-5 years’ experience facilitating health hazard evaluations (HHEs).
• Possesses in-depth skills acquired through advanced training, study and experience in diagnostics or companion diagnostics in oncology, pathology or NGS liquid biopsy.
• Experience reviewing health hazard evaluations.
• Knowledge of human factors and use error analysis is plus.
• Excellent analytical, writing, and cross functional collaboration skills.
• Risk Management ISO 14971 and international safety standards.
• Knows how to navigate FDAs MAUDE, FDA Recalls database, Canada’s MDALL, TGA’s TGA DEN and other safety databases.
• Ability to write and review clinical and diagnostic information and have strong presentation and communication skills.

Responsibilities

• Conducts and documents comprehensive health hazard evaluations (HHEs) for identified product issues, meticulously considering the clinical application and usage of the product in real-world healthcare settings.
• Ability to write, review and communicate clinical and diagnostic information.
• Reviews complaint information for compliance to procedures and assists with complaint investigations and adverse event write ups.
• Collaborate with cross-functional teams including Regulatory, Quality, Engineering, and Clinical teams to evaluate patient risk.
• Analyze and interpret product performance data and clinical literature to determine their influence on clinical outcomes, and compliance with regulatory standards.
• Demonstrates a thorough understanding and ensures compliance to FDA, EU MDR, IVDR Health Canada, etc. regulations and guidelines to author, and review HHEs and Risk Assessments.
• Monitor and interpret post market safety signals and contribute to continuous improvement in product safety.
• Collaborates with customers sponsoring clinical trials to review and assess the adequacy of the Safety Reporting plan, supporting both new and ongoing clinical studies for reporting SAEs as adverse events in accordance with IDE and global regulations.

Preferred Qualifications

• Allied health professional (AHP) or related disciplines, preferred.
• Some experience with Pathology, Cancer Screening Test, Diagnosis and Treatment regimens is preferred.