Risk Manager
$99.3k - $198.7kAbbott Laboratories
Abbott seeks a Risk Manager in Dallas to serve as division subject matter expert for risk management quality systems within the diagnostics division. The role involves developing risk management procedures, ensuring regulatory compliance, and mentoring teams across domestic and international sites.
Responsibilities
- Develop methods, tools, and procedures for conducting risk management activities
- Implement and maintain effectiveness of risk management quality system elements
- Interpret regulations and implement programs to meet worldwide risk management requirements
- Mentor and train product development and engineering teams on risk assessments
- Represent Abbott during regulatory inspections and inquiries from FDA, ISO, and AQR
Requirements
- Bachelor's degree in life science or engineering, or equivalent education and work experience
- 8-10 years of experience in product safety risk management across development, operations, or compliance
- ISO 14971 risk management experience required
- Master's degree preferred
- Medical device regulations and standards knowledge preferred
- Familiarity with IEC60601-1 or electrical safety standards desirable
Compensation: $99,300-$198,700 base
Vacancy posted 2 days ago
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