Product Performance Clinical Lead

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

Job summary

Abbott in Plymouth, MN seeks a Clinical Group Lead to provide clinical and regulatory expertise for EP and Heart Failure product lines, coordinating a small team and guiding regulatory reporting decisions.

You will train staff, develop rationales for reportability, draft inquiries responses, and stay current with FDA and global requirements while collaborating across engineering, operations and field teams.

Qualifications

• 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 with engineers, vendors, customers, field clinical engineers.

Responsibilities

• Serve as clinical/technical interface between medical community and Product Performance Group.
• Provide clinical expertise for Electrophysiology, Heart Failure and Vascular lines at all levels of the organization.
• Lead a small team of direct reports and maintain regulatory compliance program.
• Develop rationales for regulatory reportability decisions and draft responses to inquiries from regulatory bodies.

Skills

Regulatory reporting

Team leadership

Clinical expertise

FDA knowledge

Regulatory compliance

Education

Nursing

Biomedical Engineering

Job description

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 122,000 colleagues serve people in more than 160 countries.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution
• Tuition reimbursement, Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized 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.

The Opportunity

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.

Leading an active lifestyle is important to the many people we serve. 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, allowing people to restore their health and get on with their lives.

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. Maintains a regulatory compliance program and has a small team of direct reports who perform regulatory submissions. Provides clinical, regulatory and product and training for the team. Performs in a role that involves a high degree of independence.

What you’ll do

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, health care 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 to team members
• Create or update procedure documents as needed
• Provide training on patient physiology, anatomy, and disease state as well as use of products 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
• Exercise judgment within defined procedures and practices to determine appropriate action
• 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

Experience and Required Education

• 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 be able to 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 are required
• 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

Abbott is an Equal Opportunity Employer, committed to employee diversity.

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.