Analyst I Postmarket Surveillance

Abbott • Plano, TX

2d • $50,700 - $101,300 • Onsite

About The Position

The Analyst I Postmarket Surveillance position is based in Abbott’s Neuromodulation Division in Plano, Texas, and works under the direction of the department manager. The role supports complaint handling for Abbott products by receiving and investigating worldwide product complaints and events, maintaining complaint records, assessing medical-device-reporting obligations, and providing complaint information to internal teams. The role may include complaint investigation management and technical evaluation of returned products. It also supports regulatory compliance, quality systems, divisional initiatives, and communication with customers, field staff, and internal and external stakeholders.

The work environment ranges from an office or cubicle to locations encountered during travel, such as customer offices, research labs, and hospitals. Work includes substantial computer use and sitting, along with standing, walking, and frequent use of hands, arms, voice, and hearing. The position requires attention to applicable safety practices for biohazardous and chemical materials.

Requirements

• Bachelor’s degree, preferably in healthcare or science; alternatively, a two-year degree and relevant experience supporting complaint 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 as part of a team in a busy department while managing multiple ongoing tasks and investigations.
• Good problem-solving skills 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, changing environment.
• Ability to leverage or engage others to accomplish projects.
• Ability to multitask, prioritize, meet deadlines, and demonstrate strong organization, follow-up, and attention to detail.
• Ability to maintain regular and predictable attendance.
• Ability to follow safe biohazard and chemical handling practices.

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 contacts, including physicians, hospital personnel, sales representatives, and international offices, to gather information for new product complaints; initiate and manage complaint files.
• Investigate complaints and events promptly and maintain accurate complaint database entries.
• Independently assess complaints to determine whether medical device reports must be filed with global regulatory agencies, and submit reports within required timeframes.
• Prepare customer letters describing investigation findings.
• Document the condition of returned products, including observations and photographs; coordinate product testing and analysis with other departments and external consultants.
• Prepare technical reports of analyses and findings, track returned products in the database, and interpret technical product specifications, Device History Records, and measurements.
• Collaborate with cross-functional teams, including Quality Engineering and R&D, to evaluate trends and findings; participate in complaint review groups, rapid customer response teams, and Risk Management meetings as requested.
• Monitor complaint trends, archive complaint records and returned products, and retrieve information from previous investigations.
• Support complaint database upgrades and conversions by providing input and performing system testing; maintain department procedures and work instructions; support regulatory inspections as requested.
• Conduct investigations with customers or field staff, make sound medical-device-reporting decisions, determine appropriate testing of returned products, and identify when additional team support may be needed.
• Train others in product 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, cooperative communication and collaboration with employees, customers, contractors, and vendors.
• Perform other related duties as assigned.

Benefits

• Potential eligibility for free medical coverage through 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, offering 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