Risk Management Specialist(Medical device) - Intellectt : Job Details

Summary/Description

Essential Duties and Responsibilities

• To perform this job successfully, the individual must be able to perform each essential duty satisfactorily:
• Perform thorough gap assessment of existing usability and risk management documentation against EU MDR requirements and relevant standards, such as ISO 14971:2019 and IEC 62366-1:2015
• Provide risk management leadership, expertise, guidance, and supervision throughout the remediation project.
• Development of efficient and robust processes, procedures, practice, tools and technology to support continuous improvement in risk management.
• Leads development and implementation of key performance indicators and metrics for the risk management process.
• Support the post market surveillance team by creating Health Impact Assessments and Health Hazard Evaluations.

Qualifications/Experience Required

• The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
• • Bachelor's Degree in Engineering (Mechanical, Chemical, Biomedical, Electrical)
• • 5-7 years of experience of working within a medical device industry with subject matter expertise in the application of Risk Management (ISO 14971:2019) for all classes of medical devices
• • Expertise in the application of statistical techniques to support the calculation of probabilities of hazardous situations occurring (p1).
• • Expertise in industry best practices and advances in Usability Engineering and Risk Management practices, processes, tools and technology.