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.
JOB DESCRIPTION:
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…