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 Title
Analyst II, 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:
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 guidance of management,thePostmarketSurveillance Analyst IIis responsible forleading and executing complaint handling and investigation activities. This role oversees the end-to-end management of global product complaints, including intake, documentation, and thorough investigation of reported events across a diverse product portfolio. The Analyst ensuresaccurateandtimelydata entry into complaint management systems, independently assesses reportability, andsubmitsrequired medical device reports to regulatory authorities in compliance with applicable regulations.
What You'll Work On
•Initiates and manages the complaint file. Maintainsaccurateentry of complaints in the database.
•Communicates verbally and in writing both internally and externally to field representativesregardinginformation needed specific to product complaints (e.g.physicians, hospital personnel, sales representatives, international offices)
•Maintainspositive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Performs other related duties and responsibilities, on occasion, as assigned.
•Independently performsinvestigations with customers or field staff with minimal direction,utilizingexperience and knowledge of products andvarious typesof product complaints. Independently assesses the complaint todetermineif a medical device report needs to be filed with various global regulatory agencies (e.g., FDA, European Competent Authorities) and sends reports within requiredtimeframes, consulting as needed with management.
•Prepares customer letters with investigation findingsIsdiligent of any unusual trends in product complaints and communicates them tomanagement.
Participatesin cross-functional complaint review groups on a regular basis or as requested (e.g.cross-functional complaint teams, new product teams, risk management meetings).Archivescomplaint records and retrieves information on closed investigations.
•Ensuresaccuratedepartment procedures and work instructions aremaintained Train new employeestothe complaint handling processProvide support to the Legal Departmentregardingproduct complaints.
•Supports the Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirementsComplies withU.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
•Is diligent of any unusual trends in product evaluations andinformsmanagement.Independently assesses the evaluation results todetermineif they meet regulatory reporting guidelines and inform the appropriatePostmarketSurveillance team member of the findings.Participatesin cross-functional complaint review groups on a regular basis or as requested (e.g.cross-functional complaint teams, new product teams, risk management meetings)Adheres to thedeviceretention and disposal proceduresEnsuresaccuratedepartment procedures and work instructions aremaintained
•Collaborate independently with other team members and departments needing product evaluation informationBe able toascertainwhenadditionalsupport may be needed from other teams based on product evaluation findings (e.g.potential manufacturing-related issues). Train new employeestothe product evaluation process.
•Supports the Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
•Complies withU.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
•Maintainspositive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendorsPerforms 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 conditions caused by travel requirements such as customer offices, research labs, hospitals, hotels, use of automobiles, commercial travel, weather, etc.
•Activities require a significant amount of sitting in front of a computer monitor, some standing and walkingSignificant use of hands and arms, plus finger dexterity to reach, point, write, type,operatea computer and other office equipmentPerformstasks that regularly require good correctable vision and hand/eye coordination. Activities also require significant use of voice and hearing for discussions with other employees.
Required Qualifications
Preferred Qualifications
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
$61,300.00 – $122,700.00
In specific locations, the pay range may vary from the range posted.
Operations Quality
NM Neuromodulation
United States > Texas > Plano : 6600 Pinecrest
Standard
Not specified
Not Applicable
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), Continuous walking for prolonged periods (more than 2 hours at a time 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.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
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, nutritional and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and www.facebook.com/AbbottCareers, on Instagram @AbbottGlobal, and on X @AbbottNews.
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.
Terms of Use: https://www.abbott.com/social-media-terms-of-use.htm
