Senior Risk Manager - Medical Devices & Compliance

Abbott; Irving (IA); Presencial; USD 99 000 - 199 000; Tempo integral

Resumo da oferta

Abbott in Dallas, TX, within the Core Lab, Diagnostics Division, seeks a Risk Manager to serve as the SME for risk management quality systems.

You will develop methods and tools for risk activities, interpret global regulations, mentor engineering teams, and interface with regulators such as FDA and ISO to ensure compliance.

This role requires strong project leadership, cross-functional collaboration, and a deep understanding of ISO 14971 and medical device risk processes.

Qualificações

• Bachelors degree Life Science or engineering; equivalent experience accepted.
• 8–10 years in product safety risk management across R&D, NPD, ops or compliance.
• Experience with risk management (ISO 14971) required.

Responsabilidades

• Develop methods, tools, and procedures for risk management activities.
• Maintain effectiveness of the Risk Management Quality System element.
• Interpret regulations worldwide and implement risk management programs.
• SME for domestic/international sites and affiliates on Risk Management.
• Estimate effort and resources; manage tasks and timelines; identify risks.
• Interface with senior management and coordinate across units on significant matters.
• Represent the company during FDA/ISO/AQR inspections related to risk management.
• Mentor product development and sustaining engineering teams on risk assessments.
• Mentor engineering staff to prepare Health Risk Assessments.

Conhecimentos

Risk management

Regulatory compliance

Project leadership

Cross-functional collaboration

Formação académica

Bachelor’s degree Life Science/Engineering

Master’s degree preferred

Descrição da oferta de emprego

Abbott in Dallas, TX, within the Core Lab, Diagnostics Division, seeks a Risk Manager to serve as the SME for risk management quality systems.

You will develop methods and tools for risk activities, interpret global regulations, mentor engineering teams, and interface with regulators such as FDA and ISO to ensure compliance.

This role requires strong project leadership, cross-functional collaboration, and a deep understanding of ISO 14971 and medical device risk processes.