ABBOTT LABORATORIES Product Surveillance Analyst II Salary in the United States

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.

Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of STRUCTURAL HEART disease.  We aim to lead the markets we serve by requiring the solutions we offer customers provide an improved benefit/risk profile as compared to existing standards of care; a performance threshold that by definition, guides and ensures the productive output of our engineering, business development, and clinical research efforts result in outcomes that advance the standard of care.

For years, Abbott’s MEDICAL DEVICES businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring systems, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine finger sticks. 

Under the direction of the department manager, the Product Surveillance Analyst II will perform all file management activities pertaining to product complaints for the Structural Heart division of Abbott. This includes, but is not limited to: receiving and assessing 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; coordinating with internal resources to meet regulated timelines; participating on cross-functional teams

WHAT YOU’LL DO 

• Additional duties of the Product Surveillance Analyst II include: Coordination of improvement projects, initiatives and document updates for the department; Representation of the department on cross-functional teams; Assist with change roll-out to the team; CAPA ownership for department investigations.   
• Communicates verbally and in writing both internally and externally regarding information needed specific to new product complaints (e.g. physicians, hospital personnel, sales representatives, international offices), initiates and manages the complaint file
• Evaluates complaints/events accurately and in a timely manner
• Maintains accurate entry of complaints in database, following Good Manufacturing Practices (GMP) for documentation.
• 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
• 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.

EDUCATION AND EXPERIENCE YOU’LL BRING 

• Four-year 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.
• 2-3 years experience in Product Surveillance for medical products or equivalent
• Knowledge of global regulations for medical device reporting and medical terminology is a plus.
• Additionally, the Product Surveillance Analyst II must demonstrate leadership and be able to lead projects and CAPA investigations.
• 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.

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

·        Production areas that are clean, well-lit and temperature-controlled

·        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. 

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