Sr Associate Risk Management – Medical Device/Biotech (JP5077)
Thousand Oaks, CA.
Final Product Technologies
12+ months with likely extensions
3Key Consulting Inc. is recruiting for Sr Associate Risk Management with experience in key regulations and best practices for medical device risk management and human factors, for a global, CA-based, bio-pharmaceutical company.
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 Guidance) and advise management regarding potential improvements to internal Risk Management processes related to usability engineering.
Top Must-Have Skill Sets:
Day to Day Responsibilities
- 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 Guidance)
- Ability to analyze and synthesize qualitative and quantitative usable data.
- Ability to prioritize and multi-task in a fast-paced, collaborative work environment.
- Experience supporting human factors /usability engineering Risk in medical device, combination products, biotech industry.
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.
- No experience preparing for FDA submissions (medical device, biotech, Pharma).
- Does not understand human factors / usability engineering.
- No industry experience.
Phone call with 2-3 staff, possible on-site interviews.
We invite qualified candidates to send your resume to email@example.com
. If you decide that you’re not interested in pursuing this position, please feel free to look at the 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.