- Entry level
- No Education
- Salary to negotiate
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.
JOB DESCRIPTION: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
JOB FAMILY:Regulatory Operations
DIVISION:CAHF Cardiac Arrhythmias & Heart Failure
LOCATION:United States Sylmar : 15900 Valley View Court
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
About the company
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.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and www.facebook.com/AbbottCareers, on Instagram @AbbottGlobal, and on Twitter @AbbottNews and @AbbottGlobal.
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.