Analyst I Postmarket Surveillance

Abbott • Plano, TX

21h • Onsite

About The Position

The Analyst I Postmarket Surveillance position is based in Abbott’s Neuromodulation Division in Plano, Texas. Under the direction of the department manager, the analyst performs complaint-handling activities, which may include managing investigations of worldwide product complaints and events. The role involves gathering complaint information, maintaining complaint records, assessing medical-device reporting requirements, and communicating findings to internal teams and external contacts. It also involves coordinating returned-product testing and analysis, preparing reports and customer letters, and contributing to complaint review and other cross-functional activities.

The analyst works with customers, field staff, regulatory agencies, external consultants, and teams such as Regulatory, Quality Engineering, and R&D. The role requires independent judgment when conducting investigations, assessing reporting obligations, and selecting appropriate product testing, while recognizing when other teams’ support is needed. The analyst also supports complaint-system updates, procedure maintenance, regulatory inspections, training, Legal Department requests, and divisional quality and environmental management initiatives. The work environment can include an office or cubicle as well as locations encountered during travel, such as customer offices, research labs, hospitals, and hotels.

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 demonstrate 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.
• Ability to contribute as both a team member and an individual contributor in a fast-paced, 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.
• Ability to collaborate independently with team members and departments needing product complaint information and to make sound medical-device reporting decisions with minimal management input.

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

• Receive and investigate worldwide product complaints and events, including communicating with physicians, hospital personnel, sales representatives, and international offices to obtain information.
• Initiate and manage complaint files 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 specified timeframes.
• Prepare customer letters describing investigation findings.
• Document the condition of returned products, including observations and photographs; track returned products and coordinate testing or analysis with other departments and external consultants.
• Prepare technical reports of product analyses and findings, interpret product specifications, Device History Records, and measurements, and collaborate with cross-functional teams to evaluate trends and findings.
• 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 performing system testing.
• Maintain accurate department procedures and work instructions and support regulatory-agency inspections as requested.
• Conduct customer or field-staff investigations with minimal direction, use judgment to determine appropriate returned-product testing, and identify when other teams’ support is needed.
• Train others in product complaint handling and support the Legal Department with product complaints.
• Support divisional initiatives and Quality Management Systems, Environmental Management Systems, and other regulatory requirements.
• Comply with FDA regulations, other regulatory requirements, company policies, operating 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

• Career development opportunities with an international company.
• 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, described as an affordable and convenient path to earning a bachelor’s degree.

What This Job Offers

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