Analyst I, Postmarket Surveillance

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

Job summary

Abbott, headquartered in the Burlington, MA area, is seeking a candidate for the Heart Failure division to analyze customer complaints for regulatory reportability and ensure GMP adherence. The role involves coordinating with internal teams and customers, drafting regulatory documents, and maintaining compliance with CFR requirements.

The successful candidate will work under supervision with increasing responsibility, perform data collection and investigation to support MDRs and related reports,

Qualifications

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

Responsibilities

• Review complaint communications for regulatory compliance and reportability, assessing impact to patient safety and operations.
• Participate in development and modification of decision models to maintain compliance with government regulations.
• Investigate complaints by gathering data from clinical staff, field reps, internal staff and labs.
• Document regulatory reportability decisions using event investigation models.
• Draft MDRs, MedWatch, Vigilance and other regulatory reports for timely submission to authorities.
• Apply codes to events to facilitate product performance records.
• Review coding and investigations with engineering and lab staff.
• Draft written communications detailing observations, investigations, and actions to physicians and customers.

Education

Bachelor's degree in biomedical or related field

Job description

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.

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 programme, 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

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.

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.