Group Lead Clinical Product Performance

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 114,000 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. Youll 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 bachelors 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 Abbotts Electrophysiology (EP) business, were 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 Abbotts Heart Failure division, were 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 YOULL 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 Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. 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 Twitter @AbbottNews and @AbbottGlobal. 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. JOB FAMILY: Engineering DIVISION: EP Electrophysiology LOCATION: United States > Minnesota > Plymouth : 5050 Nathan Lane N ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: No MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions across the spectrum of health, around the world, for all stages of life. Whether its next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of lifes greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce. Follow Us: Facebook LinkedIn YouTube Twitter