Product Performance Clinical Lead

Thornton Tomasetti; Plymouth (MN); On-site; USD 78,000 - 156,000; Full time

Benefits offered by this job

Free HIP PPO medical plan

Strong retirement contribution

Tuition reimbursement and student debt

Job summary

Abbott is seeking a Product Performance Clinical Lead in Plymouth, MN to provide clinical and regulatory leadership within the EP Electrophysiology and Heart Failure product lines. The role includes guiding regulatory reportability decisions and leading a small team to ensure compliance with FDA and global reporting requirements.

The candidate should have a health care professional background, expertise in cardiac disease states, and strong communication skills.

Qualifications

• Health Care Professional background or related field preferred.
• Strong knowledge of patient disease states related to the heart.
• Excellent written and verbal communication across levels of the organization.

Responsibilities

• Serve as clinical and technical interface between medical community and Product Performance Group.
• Provide clinical expertise and opinions for Electrophysiology, Heart Failure and Vascular lines for all levels.
• Lead a small team of direct reports and manage regulatory reporting decisions.
• Develop rationales for regulatory reportability and train staff on product physiology and disease states.

Skills

Clinical leadership

Regulatory reporting

Medical device knowledge

Regulatory communication

Education

Nursing or Biomedical Engineering background

Tools

Regulatory reporting tools

FDA regulations knowledge

Job description

## Product Performance Clinical LeadApply: United States - Minnesota - St. Paul: Full time: Posted Today: 31164494Abbott 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 GroupProvide 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 – $156,000.00In specific locations, the pay range may vary from the range posted.## **JOB FAMILY:**Operations Quality## **DIVISION:**EP Electrophysiology## **LOCATION:**United States > Minnesota > St. Paul > Tech Center : One St Jude Medical Drive## **ADDITIONAL LOCATIONS:**## **WORK SHIFT:**Standard## **TRAVEL:**Yes, 5 % of the Time## **MEDICAL SURVEILLANCE:**Not Applicable## **SIGNIFICANT WORK ACTIVITIES:**Continuous sitting 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.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO\\_Spanish.pdf