Job Openings >> Risk Analyst - Urgent Need
Risk Analyst - Urgent Need
Summary
Title: Risk Analyst - Urgent Need
ID:71545873
Department:Development
Description

Position                            : Risk Analyst

Location                           : San Diego, CA

Duration                          : 12 Months

Total Hours/week            : 40.00

1st Shift

Client                               : Medical Devices Company

Job Category                   : Engineering/Technical

Level of Experience        : Mid-Level

Employment Type           : Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT)

 

Job Description:

Summary

  • 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).

 

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.

 

Skills and Competencies

  • Knowledge of risk assessment methodologies and tools.
  • Strong analytical skills and attention to detail.
  • Excellent communication skills

 

Qualifications and Experience

  • Bachelor’s degree in computer science, healthcare, or related field
  • 3-5 years of experience in Risk Management, preferably in a regulated industry
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