Roles & Responsibilities
- Description :
- This role will primarily be responsible for remediating Risk Management Files for medical devices to ensure compliance with ISO 14971 : 2019.
- The effort will consist of development of new and / or updating existing risk management deliverables and hazard analyses which currently comply to ISO 14971 : 2007.
- The role will require collaboration with cross-functional teams to establish accurate hazards identification and measurements using established procedures and criteria.
Responsibilities :
- Facilitate appropriate collaboration and completion of risk management deliverables including, but not limited to :
- Preliminary Hazards List
- Risk Management Plan
- System Hazards Analysis
- Risk Management Report
- Review and collaborate on other risk management deliverables including, but not limited to :
- Health Hazard Analysis
- Fault Tree Analysis
- Failure Modes and Effects Analysis
- Benefit Risk Analysis
- Conduct hazards analysis using available historical, test and market data related to the product.
- Provide timely updates to the business regarding remediation effort.
Qualification / Skill Set :
Strong cross-functional collaboration skills needed.
Experience Required
- ISO 13485 and ISO 14971 experience a plus.
- Risk management experience (preferred).
- Experience in medical device and / or regulated industry (preferred).
- Technical experience with Pyxis or automated dispensing cabinets (preferred).
Skills & Certifications
- Qualification / Skill Set :
- Strong cross-functional collaboration skills needed.
Eligibilities & qualifications
- Typically requires Bachelor’s degree and / or 5+ years of applicable experience.
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