yst 1 Requirements ysis
yst 1 Requirements ysis
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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 : Professional
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:
- 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:
- Knowledge of risk assessment methodologies and tools.
- Strong analytical skills and attention to detail.
- Excellent communication skills
Qualifications and Experience
- Bachelors degree in computer science healthcare or related field
- 35 years of experience in Risk Management preferably in a regulated industry
Employment Type
Full Time
