Risk Analyst - Urgent Need

millenniumsoft • San Diego, CA

11d

About The Position

The Risk Analyst is responsible for identifying and assessing potential risks associated with the use of a medical device, and for developing strategies to manage those risks. They bring strong product knowledge and collaborate with cross functional resources to define sequences of events which may lead to harm, thus supporting the overall risk assessment. They will support the creation and maintenance of compliance artifacts to be stored in the DHF (Design History File).

Requirements

• Knowledge of risk assessment methodologies and tools.
• Strong analytical skills and attention to detail.
• Excellent communication skills
• Bachelor’s degree in computer science, healthcare, or related field
• 3-5 years of experience in Risk Management, preferably in a regulated industry

Responsibilities

• Review existing product hazards and define the sequence of events for each
• Identify and document new hazards and risks control measures for medical device products
• Maintain accurate risk management artifacts
• Apply knowledge and understanding of ISO 14971
• Participate in product development and design reviews to identify potential risks and provide input for risk mitigation.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level