Product Performance Analyst II

Abbott • Plymouth, MN

1d • $61,300 - $122,700

About The Position

Under the direction of management, the Postmarket Surveillance Analyst may perform two different functions within complaint handling. One role is that of complaint investigation management which includes all activities pertaining to receiving and investigating reports of worldwide complaints/events on a variety of products; entering information into the complaint database; independently determining and filing appropriate medical devices reports with various regulatory agencies; participating on cross-functional teams; and providing information on product complaints to various teams (e.g. Regulatory, Quality Engineering). The other role of the Postmarket Surveillance Analyst is performing evaluations on various types of returned complaint products (e.g. disposable and implantable products, electronic and electro-mechanical medical devices and systems) such as performing non-destructive and destructive testing; reviewing of Device History Records; coordinating product testing/analysis with other SJM departments and external consultants; preparing technical reports of evaluation findings; operating and maintaining the Postmarket Surveillance Laboratory equipment.
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.

Requirements

• Bachelor's Degree in a related field
• 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

Nice To Haves

• Knowledge of U.S. Food and Drug Administration (FDA) regulations for medical device reporting
• Knowledge of global regulatory reporting requirements for medical device reporting

Responsibilities

• 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)
• 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
• 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

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level