What are the responsibilities and job description for the Risk Management Specialist position at Intellectt Inc?
Job Title: Risk Management Subject Matter Expert (SME)
Location: Remote
Key Responsibilities
- Conduct comprehensive gap assessments of usability and risk management documentation against EU MDR requirements and standards (ISO 14971:2019 and IEC 62366-1:2015).
- Provide leadership, expertise, and guidance in risk management throughout the remediation project.
- Develop efficient and robust processes, tools, and practices to improve risk management activities continuously.
- Establish and implement key performance indicators (KPIs) and metrics for the risk management process.
- Support post-market surveillance efforts by creating Health Impact Assessments and Health Hazard Evaluations.
Required Skills and Qualifications
- Education: Bachelor’s degree in Engineering (Mechanical, Chemical, Biomedical, Electrical).
- Experience:
- 5–7 years in the medical device industry with expertise in risk management for all classes of medical devices.
- Proficient in applying ISO 14971:2019 standards post-2020.
- Knowledgeable in MDR requirements and usability engineering practices.
- Expertise in applying statistical methods to calculate probabilities of hazardous situations (P1).
- Familiarity with Minitab or equivalent statistical tools is a plus.
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