Analyst I Postmarket Surveillance

Abbott Laboratories • Plano, TX

1d • $50,700 - $101,300 • Onsite

About The Position

The Analyst I Postmarket Surveillance position is based in Plano, Texas, in Abbott’s Neuromodulation Division. Under the direction of the department manager, the role supports complaint handling through complaint investigation management. This includes receiving, investigating, documenting, and managing worldwide product complaints and events; determining whether medical device reports must be filed with global regulatory agencies; and sharing complaint information with internal teams such as Regulatory and Quality Engineering.

The analyst communicates with customers and other stakeholders, investigates complaints, maintains complaint records and database entries, assesses returned products, coordinates testing and analysis, and prepares technical findings and customer letters. The role also monitors complaint trends, collaborates across functions, supports regulatory inspections and quality-system initiatives, and may train others in complaint handling. The work environment ranges from an office or cubicle to locations encountered during travel, such as customer offices, research labs, and hospitals.

Requirements

• Bachelor’s degree, preferably in healthcare or a science field; alternatively, a two-year degree and relevant experience supporting complaint-handling investigations, medical device reporting, or product analysis.
• Applicants with a degree but without medical, scientific, or complaint-handling experience may be considered if they have suitable strengths or an equivalent combination of education and work experience.
• Strong written and oral communication skills.
• Ability to work independently and on teams in a busy department while managing multiple ongoing tasks and investigations.
• Good problem-solving and proficient computer skills.
• Ability to work in a highly matrixed and geographically diverse business environment, both as a team member and individual contributor, in a fast-paced and changing environment.
• Ability to leverage or engage others to accomplish projects.
• Ability to multitask, prioritize, and meet deadlines in a timely manner.
• Strong organizational and follow-up skills and attention to detail.
• Ability to maintain regular and predictable attendance.

Nice To Haves

• Knowledge of global medical device reporting regulations and medical terminology.
• Experience working in a broader enterprise or cross-division business-unit model.

Responsibilities

• Communicate with internal and external stakeholders, including physicians, hospital personnel, sales representatives, and international offices, to obtain information for new product complaints; initiate and manage complaint files.
• Investigate complaints and events promptly and enter complaint information accurately into the database.
• Independently assess complaints to determine whether medical device reports must be filed with global regulatory agencies, and submit required reports within applicable timeframes.
• Prepare customer letters describing investigation findings.
• Document the condition of returned products, including observations and photographs, and coordinate product testing or analysis with other departments and external consultants.
• Prepare technical reports of analysis and findings; track returned products in the database as appropriate.
• Collaborate with cross-functional groups, including Quality Engineering and R&D, to evaluate trends and findings.
• Interpret technical product specifications, Device History Records, and measurement results.
• Use safe biohazard and chemical-handling practices.
• Monitor complaint data for unusual trends and participate in complaint review groups, rapid customer response teams, and Risk Management meetings as requested.
• Archive complaint records and returned products, and retrieve information from previous investigations.
• Support complaint database upgrades and conversions by providing input and conducting system testing.
• Maintain accurate departmental procedures and work instructions and support regulatory-agency inspections as requested.
• Conduct complaint investigations with customers or field staff with minimal direction; make reporting and product-testing decisions using procedures, judgment, and experience; and identify when additional team support is needed.
• Train others in Product Surveillance complaint handling and provide complaint-related support to the Legal Department.
• Support divisional initiatives and Quality Management Systems, Environmental Management Systems, and other regulatory requirements.
• Comply with FDA regulations, other regulatory requirements, company policies, procedures, processes, and task assignments.
• Maintain positive and cooperative communication and collaboration with employees, customers, contractors, and vendors.
• Perform other related duties as assigned.

Benefits

• Employees may qualify for free medical coverage in the Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• Retirement savings plan with a high employer contribution.
• Tuition reimbursement.
• Freedom 2 Save student debt program.
• FreeU education benefit, providing an affordable and convenient path to a bachelor’s degree.
• Career development opportunities with an international company.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level