Product Performance Clinical Lead

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.

About the role

This position works out of our Plymouth, MN location in the EP Division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. In Abbott’s Heart Failure division, we’re advancing the treatment of heart and vascular disease through breakthrough medical technologies in electrophysiology and heart failure. Our Product Performance Group in Plymouth has an opening for Clinical Group Lead. This role is responsible for providing clinical expertise and support to the team regarding global regulatory reporting decisions, maintaining a regulatory compliance program, and leading a small team of direct reports who perform regulatory submissions. The role involves a high degree of independence and includes providing clinical, regulatory, product, and training support.

Responsibilities

• Serve as the clinical and technical interface between the medical community and the Product Performance Group.
• Provide clinical expertise and opinions for Electrophysiology, Heart Failure, and Vascular product lines for all levels of the organization.
• Apply clinical and product knowledge to determine reportability of product complaints (malfunctions and adverse events) to global regulatory bodies (e.g., FDA).
• Lead a small team of direct reports.
• Lead a program that reviews the complaint process routinely to maintain regulatory compliance.
• Develop strong rationales for regulatory reportability decisions.
• Provide guidance to team members when assessing event reportability.
• Assist in drafting responses to inquiries from regulatory bodies, physicians, healthcare professionals, patients, field staff, and other departments.
• Review complaint files to ensure compliance with internal processes and regulatory requirements, and communicate findings to management and team members.
• Create or update procedure documents as needed.
• Provide training on patient physiology, anatomy, disease state, and product use to staff.
• Provide regulatory reporting training to small groups.
• Exercise judgment in planning, organizing, performing, coordinating, and/or directing work.
• Remain abreast of medical/technical advancements and communicate them to colleagues and associates.
• Support Health Hazard Evaluation (HHE) process.
• Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state, and federal laws and regulations.
• Promote the process of continuous quality improvement and risk management.
• Identify and coordinate solutions for process improvements.
• Maintain positive and cooperative communications and collaboration with all levels of the organization and customers.

Requirements

• Health Care Professional background, Nursing or Biomedical Engineering strongly preferred.
• Knowledge of patient disease states related to the heart.
• Ability to establish/maintain good working relationships and work cooperatively/productively with various business partners (e.g., engineers, vendors, customers, field clinical engineers).
• Ability to leverage and/or engage others to accomplish projects.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Ability to work well independently and on teams in a busy department while managing multiple ongoing tasks.
• Strong organizational and follow-up skills, as well as attention to detail.
• Problem-solving and proficient computer skills.
• Ability to travel approximately 5%, including internationally.

Preferred Qualifications

• Experience in the Cath Lab, hospital setting, or medical device.
• Knowledge of U.S. Food and Drug Administration (FDA) regulations for medical device reporting.
• Knowledge of global regulatory reporting requirements for medical device reporting.

Benefits

• Career development with an international company where you can grow the career you dream of.
• Free medical coverage in our Health Investment Plan (HIP) PPO medical plan (employees may qualify in the next calendar year).
• Excellent retirement savings plan with a high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit — an affordable and convenient path to getting a bachelor’s degree.
• Recognition as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• Recognition as one of the best big companies to work for, as well as the best place to work for diversity, working mothers, female executives, and scientists.

Pay

The base pay for this position is $78,000.00 – $156,000.00. In specific locations, the pay range may vary from the range posted.