Product Surveillance Analyst/ Complaints Handling Specialist

Spectraforce Technologies Inc Plano, TX

Title: Product Surveillance Analyst/ Complaints Handling Specialist
Location: Plano,TX 75024
Duration: 11+ months

EXP: medical device clients/medical background


Description:
  • Must have excellent computer skills (Outlook, MS Office, especially Excel) and the ability to effectively communicate, in English, both verbally and in the written form. The position is very fast-paced so the candidate must be very organized with the ability to multi-task.
  • Candidate should be able to maintain regular, predictable attendance. Skills: 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
  • Education: Four-year degree, preferably in the healthcare, science, or technical fields; or 2-year degree and 10 years of relevant experience supporting complaint handling investigations, medical device reporting, product evaluation,
  • Related work Duties: Analyst may perform two different functions within complaint handling. One role is that of complaint investigation management which includes all activities pertaining to receiving and investigating 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;
  • Participating on cross-functional teams; and providing information on product complaints to various teams (e.g. Regulatory, Quality Engineering).
  • Preference is towards candidates with some work experience: clinical experience, like nurses.
  • Previous medical device experience would be a huge plus.
  • MDR and OUS regulatory reporting experience NOT required.
  • Selected candidate is able to start once onboarding is complete.