Abbott Clinical Group Lead in Sylmar, California
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 103,000 colleagues serve people in more than 160 countries.
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
The following are required for the Clinical Group Leader role:
Health Care Professional background, BSN RN strongly preferred
Knowledge of patient disease states related to cardiac rhythm management devices, e.g. pacemakers, ICDs, leads
Ability to establish/maintain good working relationships and be able to work cooperatively/productively with various business partners, e.t. engineers, vendors, customers, field clinical engineers, and
Ability to establish/maintain good working relationships and be able to work cooperatively/productively with engineers, vendors, customers, and 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
Multitask, prioritize, and meet deadlines in a timely manner
Strong organizational and follow-up skills, with attention paid to detail
Experience in the medical device industry, preferably in the cardiac pacing industry.
Knowledge of global regulatory reporting requirements for medical devices,
Knowledge of U.S. Food and Drug Administration (FDA) regulations for medical device companies, including medical device reporting (MDR)
Knowledge of international regulatory reporting requirements for medical device reporting, e.g. MDV, TGA
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org