Abbott Postmarket Surveillance Clinical Group Lead in Sylmar, United States

At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve. Please note that candidates need to be eligible to work in the U.S. without Abbott sponsorship.

JOB DESCRIPTION:

Job Summary:

The Clinical Group Leader serves as the expert resource when medical input is required.

Key responsibilities include, but are not limited to, the following:

· Serve as the clinical and technical interface between the medical community and various departments, most frequently Postmarket Surveillance

· Provide clinical expertise and opinions for cardiac pacing products, for all levels of the organization

· Apply medical and product knowledge to determine reportability of product complaints (malfunctions and adverse events) to global regulatory bodies (e.g. FDA)

· Develop strong rationales for reportability decisions

· Provide guidance to team members when assessing event reportability

· Create or update QMS documents as needed

· Review and make the final decision on escalated or complex complaints to determine reportability of medical complaints

· Assist in drafting responses to inquiries from regulatory bodies, physicians, health care professionals, patients, field staff, and other departments

· Provide training on patient physiology, anatomy, and disease state as well as cardiac pacing products

· Review complaint files to ensure compliance with internal processes and regulatory requirements, and communicate findings to management and to team members

· 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

· 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

· Support Health Hazard Evaluation (HHE) process

· Identify and coordinate solutions for process improvements

· Maintain positive and cooperative communications and collaboration with all levels of the organization and customers

JOB FAMILY:

Engineering

DIVISION:

ASJM Abbott St. Jude Medical

LOCATION:

United States > Sylmar : 15900 Valley View Court

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Yes, 15 % 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 125 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 150 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.

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.

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