Analyst I Postmarket Surveillance

Abbott • Plano, TX

6d • Onsite

About The Position

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 122,000 colleagues serve people in more than 160 countries. 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 direction of the department manager, the Product Surveillance Analyst may perform two different functions within the complaint handling. One role would be that of complaint investigation management and includes all activities pertaining to product complaints for SJM. This includes, but is not limited to: receiving and investigating reports of worldwide complaints/events on a variety of products; entering information into the complaint database; independently determining and filing appropriate medical devices reports with various regulatory agencies; participating on cross-functional teams; and providing information on product complaints, including data extracted from the complaint database to various teams (e.g. Regulatory, Quality Engineering). Another role of the Product Surveillance Analyst is that of performing evaluations of returned complaint products, coordinating product testing/analysis with other departments and external consultants, preparing technical reports of findings and customer letters, operating and maintaining the Product Surveillance Laboratory and equipment, and collecting and evaluating analysis data. The Product Surveillance Analyst will also be able to perform trending of complaint data in either role as requested by management, including preparation of trending charts utilizing the complaint database and other programs, in support of the department Data Analyst. Depending on the site location of the PS Analyst, they may perform both complaint investigations and product analysis.

Requirements

• Bachelors Degree preferably in the healthcare or science fields; or 2-year degree and relevant experience supporting complaint handling investigations, medical device reporting, or product analysis.
• Degreed applicants without medical, scientific, or complaint handling experience may be considered if they possess the strengths suitable for this position or an equivalent combination of education and work experience.
• Strong written and oral communication skills are required.
• Candidate must be able to work well independently and on teams in a busy department while managing multiple ongoing tasks and investigations simultaneously.
• Good problem-solving and proficient computer skills are required.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage and/or engage others to accomplish projects.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.
• Ability to maintain regular and predictable attendance.

Nice To Haves

• Knowledge of global regulations for medical device reporting and medical terminology is a plus.
• Experience working in a broader enterprise/cross-division business model preferred.

Responsibilities

• Communicates verbally and in writing both internally and externally to SJM regarding information needed specific to new product complaints (e.g. physicians, hospital personnel, sales representatives, international offices), initiates and manages the complaint file
• Investigates complaints/events in a timely manner.
• Maintains accurate entry of complaints in database.
• 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.
• Prepares customer letters with findings.
• Records condition of returned products including observations, photographs.
• Coordinates product testing/analysis with other departments and external consultants.
• Prepares technical reports of analysis/findings
• Tracks returned products within the database, as appropriate
• Works collaboratively with cross-functional groups (e.g. QEs, R&D) on evaluation trends or findings
• Interprets technical product specifications, Device History Records, or measurements obtained
• Utilizes safe bio-hazard and chemical handling practices at all times.
• Is diligent of any unusual trends in product complaints
• Participates in cross-functional complaint review groups on a regular basis or as requested (e.g. cross-functional complaint teams, rapid customer response team, Risk Management meetings)
• Archives complaint records or returned products & retrieves information on previous investigations
• Supports complaint database upgrades and conversions by providing input and performing system testing
• Ensures accurate department procedures and work instructions are maintained
• Support inspections by regulatory agencies (e.g. FDA, TUV) as requested.
• Collaborate independently with other team members and departments needing product complaint information
• Be able to conduct investigations with customers or field staff with minimal direction, utilizing experience and knowledge of products and various types of product complaints
• Be able to make sound decisions regarding medical device reporting to various global regulatory agencies, minimizing the need for input from department management
• Use procedures, judgment and experience to determine appropriate testing of returned products with minimal guidance
• Be able to ascertain when additional support may be needed from other teams based on product analysis findings (e.g. potential manufacturing-related issues).
• Train others in Product Surveillance product complaint handling.
• Provide support to Legal Dept on product complaints.
• Support all Divisional initiatives as identified by divisional management and in support of 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree