Abbott Senior Specialist, Product Surveillance in Burlington, Massachusetts
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 107,000 colleagues serve people in more than 160 countries
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 heart failure, allowing people to restore their health and get on with their lives.
WHAT YOU’LL DO
Under the direction of the department manager, the Senior Specialist, Product Surveillance will be expected to be an information source for the Product Surveillance Department and be able to demonstrate sound independent decision making in regard to global medical device reporting and other functions relating to the investigation of product complaints .Additionally, will triage incoming product experiences to ensure first time quality related to complaint decisions, reportability decisions and follow up questions.
Keywords: HeartMate 3, HeartMate II, Centrimag, ECMO, Cardiovascular, ICU, Heart Failure
Assisting the department manager in ensuring all global medical device reports are filed within regulatory timeframes
Represents Product Surveillance at cross-functional meetings as requested or in the absence of the department manager
Provides training on complaint reporting to other groups
Supervision of a small team of direct reports
Supports Product Surveillance Data Analyst by performing trending
Supports complaint database upgrades, changes, conversions through design input, testing, maintenance functions
Ensures complaint information on intranet sites is maintained • Support inspections by regulatory agencies (e.g. FDA, TUV) as requested
Assists in training new employees and maintaining training documents
Is vigilant of product complaint trends
Ensures department procedures and work instructions are maintained
Supporting and instruct other department members as needed on product complaint investigations and devices
Collaborate independently with other team members and departments needing product complaint information
Act as information resource to other Product Surveillance team members
Be able to conduct investigations with customers or field staff with minimal direction, utilizing experience and knowledge of products and various types of product complaints
Be able to make sound decisions regarding medical device reporting to various global regulatory agencies, minimizing the need for input from department management
Use procedures, judgment and experience to determine appropriate testing of returned products with minimal guidance. Be able to ascertain when additional support may be needed from other teams on complaint investigations (e.g. potential manufacturing-related issues)
Train others in Product Surveillance product complaint handling
Provide support to Legal Dept on product complaints
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Performs other related duties and responsibilities, on occasion, as assigned.
EDUCATION AND EXPERIENCE YOU’LL BRING
Four-year degree, preferably in nursing or other healthcare related field; at least 2-years relevant clinical experience in order to support complaint handling investigations, medical device reporting, or product analysis.
Knowledge of global regulations for medical device reporting and complaint handling is a must. Candidate must be able to work well independently and on teams in a busy department while managing multiple ongoing tasks and investigations simultaneously.
Problem-solving and proficient computer skills are required.
Experience working in a broader enterprise/cross-division business unit model preferred.
Ability to work in a highly matrixed and geographically diverse business environment.
Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
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.
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer:
Training and career development , with onboarding programs for new employees and tuition assistance
Financial security through competitive compensation, incentives and retirement plans
Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
Paid time off
401(k) retirement savings with a generous company match
The stability of a company with a record of strong financial performance and history of being actively involved in local communities
*Learn more about our benefits that add real value to your life to help you live fully: * www.abbottbenefits.com at http://www.abbottbenefits.com/pages/candidate.aspx
Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com at http://www.abbott.com/ , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
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