Product Performance Clinical Lead

Job ID: 31158517Company: Abbott LaboratoriesLocation: United States - Minnesota - PlymouthJob Type: Full timeCategory: OperationsIndustry: HealthcarePosted Date: 2026-08-12Abbott 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 AbbottAt 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 contributionTuition 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 OpportunityThis 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 DOServe as the clinical and technical interface between the medical community and the Product Performance GroupProvide clinical expertise and opinions for Electrophysiology, Heart Failure and Vascular product lines for all levels of the organizationApply 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 reportsLead a program that reviews the complaint process routinely to maintain regulatory complianceDevelop strong rationales for regulatory reportability decisionsProvide guidance to team members when assessing event reportabilityAssist in drafting responses to inquiries from regulatory bodies, physicians, health care professionals, patients, field staff, and other departmentsReview complaint files to ensure compliance with internal processes and regulatory requirements, and communicate findings to management and to team membersCreate or update procedure documents as neededProvide training on patient physiology, anatomy, and disease state as well as use of products to staffProvide regulatory reporting training to small groupsExercise judgment in planning, organizing, performing, coordinating and/or directing workRemain abreast of medical/technical advancements and communicate them to colleagues and associatesExercise judgment within defined procedures and practices to determine appropriate actionSupport Health Hazard Evaluation (HHE) processReview 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 managementIdentify and coordinate solutions for process improvementsMaintain positive and cooperative communications and collaboration with all levels of the organization and customersExperience and Required EducationHealth Care Professional background, Nursing or Biomedical Engineering strongly preferredKnowledge of patient disease states related to the heartAbility to establish/maintain good working relationships and be able to work cooperatively/productively with various business partners, e.g. engineers, vendors, customers, field clinical engineersAbility to leverage and/or engage others to accomplish projectsStrong verbal and written communications with ability to effectively communicate at multiple levels in the organizationAbility to work well independently and on teams in a busy department while managing multiple ongoing tasksStrong organizational and follow-up skills, as well as attention to detailProblem-solving and proficient computer skills are requiredAbility to travel approximately 5%, including internationallyPreferred Qualifications:Experience in the Cath Lab, hospital setting or medical deviceKnowledge of U.S. Food and Drug Administration (FDA) regulations for medical device reportingKnowledge of global regulatory reporting requirements for medical device reportingApply NowLearn more about our health and wellness benefits, which provide the security to help you and your family live full lives: 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 , on Facebook at , 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.Skillsregulatory complianceproduct performance managementfda regulatory submissionsteam leadershipclinical expertiseregulatory reportingcomplaint managementhealth hazard evaluationrisk managementtraining deliveryprocess improvementmedical device regulationscath lab experiencehospital setting experiencebiomedical engineeringpatient physiology traininganatomy trainingproduct trainingproblem solvingorganizational skillsverbal communicationwritten communicationcomputer skills