Sr Associate Risk Management (JP5175)

Location: Thousand Oaks, CA
Date Posted: 01-04-2019
Job Title: Sr Associate Risk Management (JP5175)
Location: Thousand Oaks, CA
Employment Type: Contract
Duration: 11 months with likely extensions
Business Unit:  Device Quality 
 
‚Äč3Key Consulting is looking for a Sr Associate Risk Management for a leading, international pharmaceutical company headquartered in Thousand Oaks, CA.
 Job Summary:
  • Primary responsibility for creating and maintaining usability risk analyses for combination and non-combination products working closely with Device Engineering, Device Quality, extended Risk team, Global Safety, Regulatory, and Human Factors / Usability Engineers. 
  • Supporting documentation review and development, including but not limited to hazard analysis, use risk analyses, task analyses, use specifications, safety assurance cases, uFMEAs, root cause analysis, traceability of risk mitigations and controls, and Human Factors Engineering reports to support regulatory filings. 
  • Work with complaints team to analyze on-market product complaints using risk-based decision making, and update usability risk assessment and escalate usability-related issues as necessary 
  • Sound understanding of key regulations and best practices for medical device risk management and human factors (e.g. 14971, IEC 62366, AAMI HE75, FDA Applying Human Factors and Usability Engineering to Medical Devices, FDA Combination Products Guidances) and advise management regarding potential improvements to internal Risk Management processes related to usability engineering.
 Top Must have Skill Sets:

1. Sound understanding of key regulations and best practices for medical device risk management and human factors (e.g. 14971, IEC 62366, AAMI HE75, FDA Applying Human Factors and Usability Engineering to Medical Devices, FDA Combination Products Guidances)
2. Ability to analyze and synthesize qualitative and quantitative usable data.
3. Ability to prioritize and multi-task in a fast-paced, collaborative work environment.
4. Experience supporting human factors /usability engineering Risk in medical device, combination products, biotech industry.

Day-To-Day Responsibilities:
Provide Use-related risk management support across multiple programs. Support Hazard identification, risk analysis, complaint investigations of internal products, collection and synthesis of data for design inputs, FDA responses, task analysis, Identification of critical tasks, and product validation for combination and non-combination products. Conduct risk sessions using DAI process. Identify Risk and provide solutions.
 
Employee Value Proposition: This is a great opportunity for someone to grow upon their Human Factors Engineering experience within risk management field.
  
Red Flags: No experience preparing for FDA submissions (medical device, biotech, Pharma). Does not understand human factors / usability engineering. No industry experience. We are NOT looking for a Project Manager. We need someone who can execute the work themselves.
 
Interview Process: Phone call with 2-3 staff, possible on-site interviews.
  
We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.**No Third-party Vendors Please**
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Regards,
 
3KC Talent Acquisition Team
 
 
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