Senior Specialist, Product Performance, Medical Affairs

Responsibilities

• Oversee on-market product and clinical study performance, including post-market clinical data from commercial use.
• Monitor product safety related items such as complaints and Medical Device Reporting (MDRs).
• Evaluate product performance data and trends to identify potential clinical safety risks or usage concerns.
• Investigate customer complaints by gathering data from clinical staff, field representatives, and laboratory analysis.
• Coordinate reporting information for regulatory agencies and ensure compliance with all safety regulations.
• Serve as a key resource in risk management, MDR reporting, and post-market product experience.
• Collaborate cross-functionally with Compliance, Clinical Science, Regulatory Affairs, and Commercial organizations.

Requirements

• Bachelor's Degree in Pharmacy, Nursing, RT, Life Science, or another health-related field.
• 5+ years of relevant professional experience.
• Experience working in a quality-related role or equivalent experience in a clinical laboratory, medical clinic, or nursing.

Preferred Qualifications

• MD, RN, or RT with Cath Lab experience.
• Background in cardiology, cardiac surgery, or vascular medicine/surgery.
• Strong project management skills and the ability to manage initiatives across multiple functions.
• Ability to work effectively in a highly matrixed, fast-paced, and geographically diverse business model.
• Excellent verbal and written communication skills for interacting at multiple levels of the organization.
• Willingness to travel approximately 10%, including potential international travel.

Benefits

• Career development opportunities within a global international company.
• Access to medical coverage through the Health Investment Plan (HIP) PPO plan.
• Excellent retirement savings plan with high employer contributions.
• Tuition reimbursement and specialized student debt and education programs.

About the Company

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans diagnostics, medical devices, nutritionals, and branded generic medicines, serving people in more than 160 countries.