Risk Manager, Quality Systems & Regulatory Compliance

Abbott Laboratories; Irving (TX); On-site; USD 99,000 - 199,000; Full time

Benefits offered by this job

HIP PPO Medical plan

Retirement plan

Tuition reimbursement

Job summary

Abbott Laboratories in Dallas, TX is seeking a Risk Manager to serve as the Division SME for Risk Management quality systems worldwide. You will develop methods and oversee implementation, mentor engineering teams, and ensure compliance with ISO 14971 across the Diagnostics Division.

The role partners with cross‑functional teams to assess risk, plan resources, and coordinate inspections by regulators such as FDA and ISO, contributing to safer medical devices and healthier futures.

Qualifications

• Bachelor's degree in life sciences or engineering; related experience acceptable.
• 8-10 years of experience in product safety risk management across R&D, manufacturing, operations or compliant handling.
• Experience with risk management (ISO 14971) required.

Responsibilities

• Develop methods, tools, and procedures for risk management activities.
• Implement and maintain the Risk Management Quality System element.
• Interpret regulations and implement programs worldwide for Risk Management.
• Serve as SME for domestic and international sites regarding Risk Management Quality System element.
• Mentor, coach and train engineering staff to prepare Health Risk Assessments.

Skills

Risk management

ISO 14971

Regulatory knowledge

Education

Bachelor's degree Life Science or engineering

Master's degree (preferred)

Job description

Abbott Laboratories in Dallas, TX is seeking a Risk Manager to serve as the Division SME for Risk Management quality systems worldwide. You will develop methods and oversee implementation, mentor engineering teams, and ensure compliance with ISO 14971 across the Diagnostics Division.

The role partners with cross‑functional teams to assess risk, plan resources, and coordinate inspections by regulators such as FDA and ISO, contributing to safer medical devices and healthier futures.