Senior Clinical Risk & Program Manager (Medical Devices)

Abbott; Saint Paul (MN); On-site; USD 78,000 - 156,000; Full time

Benefits offered by this job

HIP PPO Coverage

Retirement plan with employer contrib

Tuition reimbursement

FreeU education benefit

Job summary

Abbott is seeking a Clinical Risk Evaluation (CRE) Senior Scientist/Program Manager to provide technical and strategic expertise across the product life cycle for Neuromodulation risk management. You will manage Risk Evaluation Files, perform risk analyses, and interact with cross-functional teams to support strategy, plans, and deliverables.

The role requires coordinating CERs/SSCPs, leading risk alignment meetings, and implementing regulatory strategies while ensuring timelines and quality

Qualifications

• Bachelor’s degree in a related field or equivalent experience.
• Minimum 6 years’ related work experience in clinical risk or medical devices.
• Solid knowledge of MEDDEV 2.7/1 Rev.4 and MDR Article 61.
• Experience working in a quality system environment.

Responsibilities

• Lead creation and maintenance of Risk Evaluation Files (REFs) for Abbott products.
• Coordinate risk alignment meetings with cross‑functional teams and leadership.
• Develop and maintain CERs, SSCPs, and related regulatory documents.
• Guide regulatory responses for Notified Body questions and audits.
• Provide strategic risk guidance to product development and sustaining teams.
• Mentor junior staff and manage multiple projects concurrently.

Skills

Risk Evaluation

Project Management

Regulatory Knowledge

Clinical Data

Cross-Functional Leadership

Medical Device

Education

Bachelor's Degree in related field

Master's degree

Job description

Abbott is seeking a Clinical Risk Evaluation (CRE) Senior Scientist/Program Manager to provide technical and strategic expertise across the product life cycle for Neuromodulation risk management. You will manage Risk Evaluation Files, perform risk analyses, and interact with cross-functional teams to support strategy, plans, and deliverables.

The role requires coordinating CERs/SSCPs, leading risk alignment meetings, and implementing regulatory strategies while ensuring timelines and quality