Product Surveillance Analyst 1

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 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.
• A company recognized as a great place to work in dozens of countries 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 St Paul, MN location in the Electrophysiology division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.

What You’ll Work On

• Postmarket Surveillance Analyst may perform two different functions within complaint handling. One role is that of complaint investigation management which includes all activities pertaining 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 to various teams (e.g. Regulatory, Quality Engineering).
• The other role of the Postmarket Surveillance Analyst is performing evaluations on various types of returned complaint products (e.g. disposable and implantable products, electronic and electro-mechanical medical devices and systems) such as performing non-destructive and destructive testing; reviewing of Device History Records; coordinating product testing/analysis with other SJM departments and external consultants; preparing technical reports of evaluation findings; operating and maintaining the Postmarket Surveillance Laboratory equipment.

Required Qualifications

• Four-year degree, preferably in the healthcare, science, or technical fields; or 2-year degree and 10 years of relevant experience supporting complaint handling investigations, medical device reporting, product evaluation, or related work
• Knowledge of global regulations for medical device reporting and medical terminology is a plus
• 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
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.

The base pay for this position is $50,000.00 – $100,000.00. In specific locations, the pay range may vary from the range posted.