Analyst II, Postmarket Surveillance (Regulatory Evaluation Team) at Abbott

Plano, Texas, United States of America
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.
Postmarket Surveillance Analyst II performs evaluations of returned complaint products, coordinating product testing/analysis with other departments and external consultants, preparing technical reports of findings and customer letters, operating and maintaining the Product Surveillance Laboratory and equipment, and collecting and evaluating analysis data. The Product Surveillance Analyst will also be able to perform trending of complaint data in either role as requested by management, including preparation of trending charts utilizing the complaint database and other programs, in support of the department Data Analyst. Depending on the site location of the PS Analyst, they may perform both complaint investigations and product analysis.
Job Duties:.

  • 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
  • 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, judgement and experience to determine appropriate testing of returned products with minimal guidance
  • 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 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:

  • RN or BME are highly preferred
  • 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.
  • 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.
  • 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.
  • 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 maintain regular and predictable attendance.

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