ABBOTT LABORATORIES Post Market 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 103,000 colleagues serve people in more than 160 countries.

Under the direction of the department manager, the Post Market Surveillance Analyst II will

perform the same duties as the Post Market Surveillance Analyst, and depending on their location, may perform both the role of CVD product complaint investigation and returned product analysis. 

Job Duties:

• Assisting the department manager in ensuring all global medical device reports are filed within regulatory timeframes
• Represents Product Surveillance at cross-functional meetings as requested or in the absence of the department manager
• May lead a small team of direct reports.
• Provides training on complaint reporting to other groups
• Supports Product Surveillance Data Analyst by performing trending
• Supports complaint database upgrades, changes, conversions through design input, testing, maintenance functions
• Ensures complaint information on intranet sites is maintained
• Orders department supplies in accordance with budget
• Support inspections by regulatory agencies (e.g. FDA, TUV) as requested
• Assists in training new employees and maintaining training documents
• Is vigilant of product complaint trends
• Ensures department procedures and work instructions are maintained
• Supporting and instruct other department members as needed on product complaint investigations and devices
• Collaborate independently with other team members and departments needing product complaint information
• Act as information resource to other Product Surveillance team members
• 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
• Perform CAPA investigations as they relate to complaint reporting
• Be able to ascertain when additional support may be needed from other teams on complaint investigations (e.g. potential manufacturing-related issues)
• Train others in Product Surveillance product complaint handling
• May support department manager in their absence
• Provide support to Legal Dept on product complaints
• Support all Company initiatives as identified by 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.

Qualifications:

• 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. 
• 2-3 yrs for Product Surveillance Experience
• Knowledge of global regulations for medical device reporting and complaint handling is a must. Strong written and oral communication skills are required.
• 1 plus years of experience with CAPA
• Candidate must be able to work well independently and on teams in a busy department while managing multiple ongoing tasks and investigations simultaneously.
• 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 provide guidance to a small team of direct reports.
• Ability to leverage and/or engage others to accomplish projects.

• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.
• Ability to travel approximately 5%, including internationally.