Analyst II, Postmarket Surveillance

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 115,000 colleagues serve people in more than 160 countries. 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 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 and a student debt program – an affordable and convenient path to getting a bachelor’s degree. A company recognized as a great place to work 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. Responsibilities Initiates and manages the complaint file and maintains accurate entry of complaints in the database. Communicates verbally and in writing to field representatives and other stakeholders regarding information needed for product complaints. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Independently performs investigations with minimal direction, utilizing experience and knowledge of products and various types of product complaints. Assesses the complaint to determine if a medical device report needs to be filed with global regulatory agencies (e.g., FDA, European Competent Authorities) and submits reports within required timeframes. Prepares customer letters with investigation findings. Reacts to 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 and trains new employees on the complaint handling 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 and other regulatory requirements, company policies, operating procedures, processes, and task assignments. 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. The base pay for this position is $61,300.00 – $122,700.00. In specific locations, the pay range may vary from the range posted. Abbott is an Equal Opportunity Employer, committed to employee diversity. #J-18808-Ljbffr Abbott Laboratories