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 115,000 colleagues serve people in more than 160 countries.
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:
Career development with an international company where you can grow the career you dream of.
Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
An excellent retirement savings plan with 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 around the world 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 a best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
This position works out of our Burlington, MA location in the Heart Failure division. In Abbott’s Heart Failure (HF) business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives. Senior Analyst will Analyze customer complaints to determine which are regulatory reportable and coordinates activities with internal, field, and end use customers. Be responsible for adherence to Good Manufacturing Practices (GMPs) and proper complaint handling per the Code of Federal Register (CFR) and other governmental regulations. Communicates event investigation results via regulatory reports and written communications, as appropriate.
What You’ll Work On
Review complaint communications and assess for regulatory compliance, reportability, and potential impact to patient safety and business operations.
Apply clinical knowledge, as related to product application, to evaluate identified complaints.
Investigate complaints by gathering sufficient data from clinical staff, field representatives, internal employees, and laboratory analysis.
Establish regulatory reportability decisions using event investigation and regulatory decision models.
Participate in development and modification of these decision models with changes in product advances/therapies to uphold consistent compliance with government mandated regulations.
Write Medical Device Reports (MDRs), MedWatch, Vigilance, and other regulatory reports, ensuring timely transmission to the appropriate regulatory authorities.
Apply codes to events to facilitate product performance records.
Review coding and investigations with engineering, laboratory, and other internal staff.
Compose written communications detailing the clinical observation, investigation and/or product analysis, and corrective actions, as applicable, to physician and other end use customers.
Communications include determination/eligibility for warranty credit or unreimbursed medical payments.
Writes and communicates position papers pertaining to clinical perspective for regulatory reporting, performing literature research, consulting with outside clinical resources to ensure pertinent information is properly disseminated
Required Qualifications:
Bachelor's Degree
Minimum 6 years of related work experience with a strong understanding of specified functional area.
Solid understanding and application of business concepts, procedures and practices.
Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
Has a sound knowledge of a variety of alternatives and their impact on their business unit.
Preferred Qualifications:
Master's Degree
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews
The base pay for this position is $78,000.00 – $156,000.00. In specific locations, the pay range may vary from the range posted.