Analyst I, Postmarket Surveillance

Abbott Laboratories; Burlington (MA); On-site; USD 51,000 - 101,000; Full time

Benefits offered by this job

HIP PPO health coverage

Tuition reimbursement

FreeU education benefit

High employer retirement contribution

Job summary

Abbott Laboratories in Burlington, MA is seeking a Regulatory/Quality Specialist in the Heart Failure division. You will analyze customer complaints to determine regulatory reportability and coordinate with internal teams to ensure GMP compliance.

The role involves drafting MDRs and regulatory reports, applying codes, and communicating investigation results to physicians and end users. Bachelor's degree in biomedical or related field and 0–2 years of experience required.

Qualifications

• Bachelor's degree in biomedical or related field.

Responsibilities

• Review complaints for regulatory reportability and impact on patient safety and business operations.
• Develop and modify decision models to align with product advances and regulations.
• Investigate identified complaints with data from clinical staff, field reps, internal teams and labs.
• Document regulatory decisions using event investigations and decision models.
• Draft Medical Device Reports (MDRs), MedWatch and other reports for regulatory authorities.

Education

Bachelor's degree in biomedical or related field

Job description

JOB DESCRIPTION:

Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your 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.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a 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 worldwide 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 the 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.

This role analyzes customer complaints to determine which are regulatory reportable and coordinates activities with internal, field, and end use customers. 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.
• Participate in development and modification of these decision models with changes in product advances/therapies to uphold consistent compliance with government-mandated regulations.
• Evaluate and investigate identified complaints by gathering sufficient data from clinical staff, field representatives, internal employees, and laboratory analysis.
• Collect, compile, and document regulatory reportability decisions using event investigation and regulatory decision models.
• Draft 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.
• Draft 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.
• Begins establishing and cultivating a network of internal resources to facilitate completion of tasks.
• Individual influence is typically exerted at the peer level.
• Completes daily work to meet established schedule with guidance from supervisor on prioritization of tasks.
• May exercise authority within pre-established limits and approval.
• Failure to achieve results can normally be overcome without serious effect on the business.

Required Qualifications

• Bachelor's degree in biomedical or related field
• 0-2 years of related work experience

Abbott is an Equal Opportunity Employer, committed to employee diversity.

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.

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 $50,700.00 – $101,300.00. In specific locations, the pay range may vary from the range posted.

JOB FAMILY: Operations Quality DIVISION: HF Heart Failure LOCATION: United States > Massachusetts > Burlington : 168 Middlesex Turnpike ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 10 % of the Time MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)

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 135 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 160 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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