Senior Clinical Risk & Program Manager

Abbott; Plano (TX); On-site; USD 78,000 - 156,000; Full time

Benefits offered by this job

HIP medical plan

Retirement plan

Tuition reimbursement

Education benefit

Job summary

Abbott Laboratories is seeking a CRE Senior Scientist/Program Manager to provide strategic risk evaluation leadership across product life cycles. You will manage REF development, lead cross-functional risk discussions, and guide clinical evaluation reporting to ensure compliance and timely deliverables.

The role requires coordinating with Regulatory Affairs, R&D, and Quality teams while maintaining rigorous documentation and adherence to regulatory standards.

Qualifications

• Bachelor’s Degree or equivalent in a related field.
• 6+ years of related experience in medical device or clinical risk evaluation.
• Knowledge of MEDDEV 2.7/1 Rev.4 and MDR Article 61.
• Ability to manage multiple projects and meet timelines.
• Excellent communication across cross-functional teams.

Responsibilities

• Create and maintain Risk Evaluation Files (REFs) for Abbott products.
• Lead risk alignment meetings with cross-functional teams.
• Develop and maintain REF documentation and SOP templates.
• Guide CER/SSCP development and manage timelines.
• Coordinate regulatory submissions and responses with Regulatory Affairs.

Skills

Risk Evaluation

Project management

Cross-functional collaboration

Regulatory affairs

Education

Bachelor's Degree in related field

Master’s degree (preferred)

Job description

Abbott Laboratories is seeking a CRE Senior Scientist/Program Manager to provide strategic risk evaluation leadership across product life cycles. You will manage REF development, lead cross-functional risk discussions, and guide clinical evaluation reporting to ensure compliance and timely deliverables.

The role requires coordinating with Regulatory Affairs, R&D, and Quality teams while maintaining rigorous documentation and adherence to regulatory standards.