Product Performance Clinical Lead

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

Benefits offered by this job

Free medical coverage

Excellent retirement plan

Tuition reimbursement

Education benefits

Job summary

Abbott is seeking a Clinical Group Lead in Plymouth, MN, to provide clinical and regulatory leadership within EP Electrophysiology and Heart Failure product lines. The role supports global regulatory reporting decisions and maintains compliance across teams.

The position requires a health care professional background, strong communication, and the ability to travel ~5%. Abbott offers comprehensive development, health coverage, retirement savings, and tuition programs.

Qualifications

• Health care professional background preferred.
• Knowledge of patient disease states related to the heart.
• Ability to lead and collaborate with diverse partners.

Responsibilities

• Serve as clinical and technical interface between medical community and Product Performance Group.
• Provide clinical expertise for Electrophysiology, Heart Failure and Vascular lines.
• Assess reportability of product complaints to global regulatory bodies (e.g. FDA).
• Lead a small team of direct reports and oversee regulatory processes.
• Develop rationales for regulatory reportability decisions.
• Draft responses to inquiries from regulatory bodies and health professionals.

Skills

Clinical expertise

Regulatory knowledge

Leadership

Communication

Problem-solving

Education

Healthcare professional background

Job description

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 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

The base pay for this position is $78,000.00 – $156,000.00

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.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 it’s 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 life’s greatest health challenges.

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