Analyst II, Postmarket Surveillance
Abbott
Plano, Texas
Full-Time
$61,300
HybridAssociate
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:
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 guidance of management, the Postmarket Surveillance Analyst II is responsible for leading 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 ensures accurate and timely data entry into complaint management systems, independently assesses reportability, and submits required medical device reports to regulatory authorities in compliance with applicable regulations.
What You'll Work On
• Initiates and manages the complaint file. Maintains accurate entry of complaints in the database.
• Communicates verbally and in writing both internally and externally to field representatives regarding information needed specific to product complaints (e.g. physicians, hospital personnel, sales representatives, international offices).
•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.
• Independently performs investigations with customers or field staff with minimal direction, utilizing experience and knowledge of products and various types of product complaints. 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, consulting as needed with management.
• Prepares customer letters with investigation findings. Is diligent of any unusual trends in product complaints and communicates them to management.
Participates in cross-functional complaint review groups on a regular basis or as requested (e.g. cross-functional complaint teams, new product teams, risk management meetings). Archives complaint records and retrieves information on closed investigations.
• Ensures accurate department procedures and work instructions are maintained. Train new employees to the complaint handling process. Provide support to the Legal Department regarding product complaints.
• Supports the 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.
• Is diligent of any unusual trends in product evaluations and informs management. Independently assesses the evaluation results to determine if they meet regulatory reporting guidelines and inform the appropriate Postmarket Surveillance team member of the findings. Participates in 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 the device retention and disposal procedures. Ensures accurate department procedures and work instructions are maintained.
• Collaborate independently with other team members and departments needing product evaluation information. Be able to ascertain when additional support may be needed from other teams based on product evaluation findings (e.g. potential manufacturing-related issues). Train new employees to the product evaluation process.
• Supports the 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 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 walking. Significant use of hands and arms, plus finger dexterity to reach, point, write, type, operate a computer and other office equipment. Performs tasks 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
Associate’s Degree plus 10 years of relevant experience supporting complaint handling investigations, medical device reporting, product evaluation, or related work; or an equivalent combination of education and work experience
Preferred Qualifications
Bachelor’s Degree preferably in healthcare, science, or technical fields
Equivalent combination of education and work experience
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.
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The base pay for this position is
$61,300.00 – $122,700.00In specific locations, the pay range may vary from the range posted.