St. Jude Medical Analyst II, Postmarket Surveillance in Plano, Texas

Analyst II, Postmarket Surveillance


Plano, Texas, USA at

Quality at

Global Operations-Supply Chain-Quality

1600022YRequisition #

Apply for Job

Share this Job

Sign Up for Job Alerts

We are seeking an experienced, high caliber Analyst II, Postmarket Surveillance to perform complaint management which includes independently determining and filing appropriate medical devices reports with various regulatory agencies; entering of complaints into the database; participating on cross-functional teams; and providing information on product complaints to various teams.

Each employee can make a difference at St. Jude Medical and has the power, either individually or as a team, to influence the success of the company. We are team-oriented, fast-paced and progressive. We value people with great ideas who partner with others both internally and externally to take action and accomplishgoals.

Impact this role will have on St. Jude Medical:

  • Initiates and manages the complaint file

  • Maintains accurate entry of complaints in the database

  • Communicates verbally and in writing both internally and externally to field representatives regarding information needed specific to product complaints (e.g. physicians, hospital personnel, sales representatives, international offices)

  • Independently performs investigations with customers or field staff with minimal direction, utilizing experience and knowledge of products and various types of product complaints

  • 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, consulting as needed with management

  • Is diligent of any unusual trends in product complaints and communicates them to management

  • Participates in cross-functional complaint review groups on a regular basis or as requested (e.g. cross-functional complaint teams, new product teams, risk management meetings)

  • Provide support to the Legal Department regarding product complaints

  • Supports the 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

Your experience(s), education and knowledge will further expand St. Jude Medical’s marketplace success:

  • 4-year degree, preferably in the healthcare (e.g. cardiac nursing, cath lab experience), 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

  • 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

  • Effectively multitasks, prioritizes and meets timelines

  • Strong organizational and follow-up skills, as well as attention to detail

  • Ability to maintain regular and predictable attendance