Analyst I Postmarket Surveillance

About this role

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. JOB DESCRIPTION: Job Title Analyst I Postmarket Surveillance

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 Plano, TX location in the Neuromodulation Division.  Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum.

Under the direction of the department manager, the Postmarket Surveillance Analyst I may perform two different functions within the complaint handling. One role would be that of complaint investigation management and includes all activities pertaining to product complaints for Abbott. This includes, but is not limited to: receiving and investigating reports of worldwide complaints/events on a variety of products; entering information into the complaint database; independently determining and filing appropriate medical devices reports with various regulatory agencies; participating on cross-functional teams; and providing information on product complaints, including data extracted from the complaint database to various teams (e.g. Regulatory, Quality Engineering). 

What You’ll Work On • Communicates verbally and in writing both internally and externally to SJM regarding information needed specific to new product complaints (e.g. physicians, hospital personnel, sales representatives, international offices), initiates and manages the complaint file

• Investigates complaints/events in a timely manner.  Maintains accurate entry of complaints in database.  Independently assesses the complaint to determine if a medical device report needs to be filed with various global regulatory agencies (e.g., FDA, European Competent Authorities) and sends reports within required timeframes.  Prepares customer letters with findings.  Records condition of returned products including observations, photographs. Coordinates product testing/analysis with other departments and external consultants.

• Prepares technical reports of analysis/findings--Tracks returned products within the database, as appropriate;  Works collaboratively with cross-functional groups (e.g. QEs, R&D) on evaluation trends or findings;  Interprets technical product specifications, Device History Records, or measurements obtained; and Utilizes safe bio-hazard and chemical handling practices at all times.

• Duties associated with either role: Is diligent of any unusual trends in product complaints; Participates in cross-functional complaint review groups on a regular basis or as requested (e.g. cross-functional complaint teams, rapid customer response team, Risk Management meetings);  Archives complaint records or returned products & retrieves information on previous investigations; Supports complaint database upgrades and conversions by providing input and performing system testing; Ensures accurate department procedures and work instructions are maintained; and support inspections by regulatory agencies (e.g. FDA, TUV) as requested.

• The Product Surveillance Analyst must be able to:  Collaborate independently with other team members and departments needing product complaint information;  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;  and be able to ascertain when additional support may be needed from other teams based on product analysis findings (e.g. potential manufacturing-related issues)

• Train others in Product Surveillance product complaint handling.  Provide support to Legal Dept on product complaints.  Support all Divisional initiatives as identified by divisional 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.

• Work environment varies from well lighted office/cubicle, low to moderate noise level, to a variety of co

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