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Risk Analyst - Urgent Need
Risk Analyst - Urgent NeedMILLENNIUMSOFT • San Diego, CA, United States
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Risk Analyst - Urgent Need

Risk Analyst - Urgent Need

MILLENNIUMSOFT • San Diego, CA, United States
[job_card.variable_days_ago]
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  • [job_card.full_time]
[job_card.job_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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