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 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, the 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

Apply Now

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com , on Facebook at www.facebook.com/Abbott , and on X @AbbottNews.

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.