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 113,000 colleagues serve people in more than 160 countries.

Leading an active lifestyle is important to the many people we serve. In Abbott’s Electrophysiology and Heart Failure division, we’re advancing the treatment of heart and vascular disease through breakthrough medical technologies in electrophysiology and heart failure, allowing people to restore their health and get on with their lives.

WHAT YOU’LL DO

• 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 Maintain inventory of packaging materials

• 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; and Utilizes safe bio-hazard and chemical handling practices at all times.

• Duties associated with either role: 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; and support inspections by regulatory agencies (e.g. FDA, TUV) as requested.

• The Product Surveillance Analyst must be able to:  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;  and 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.

• Work environment varies from well lighted office/cubicle, low to moderate noise level, to a variety of conditions caused by travel requirements such as customer offices, research labs, hospitals, hotels, use of automobiles, commercial travel, weather, etc.

• Activities require a significant amount of sitting in front of a computer monitor,

• some standing and walking.  Significant use of hands and arms, plus finger dexterity to reach, point, write, type, operate a computer and other office equipment.  Performs tasks that regularly require good correctable vision and hand/eye coordination. Activities also require significant use of voice and hearing for discussions with other employees.

EDUCATION AND EXPERIENCE YOU’LL BRING

Required

• Bachelors Degree (± 16 years) or 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.

• Experience working in a broader enterprise/cross-division business unit model preferred. 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.

Preferred

• Forklift experience preferred

• Knowledge of global regulations for medical device reporting and medical terminology is a plus.

• Multitasks, prioritizes and meets deadlines in timely manner. Strong organizational and follow-up skills, as well as attention to detail.

• Ability to travel, including internationally. Ability to maintain regular and predictable attendance.

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:

• A fast-paced work environment where your safety is our priority (Include for Manufacturing roles only)
• Production areas that are clean, well-lit and temperature-controlled (Include for Manufacturing roles only)
• Training and career development, with onboarding programs for new employees and tuition assistance
• Financial security through competitive compensation, incentives and retirement plans
• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
• Paid time off
• 401(k) retirement savings with a generous company match
• The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.