Risk Analyst

Position: Risk Analyst

Location: San Diego, CA 92121

Duration: 12 Months Contract with possible extension

Pay Rate: $35/hr - $39/hr (depending on experience)

Relocation Expenses/ Assistance: NO

Job Description:

• 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).
• 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.

Job Requirement:

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