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Analyst, Product Surveillance

Spectraforce Technologies
United States, Massachusetts, Burlington
May 02, 2024
Job Title: Analyst, Product Surveillance Duration: 8-12 Months Location: Burlington, MA 01803 Schedule- 9am-5pm Job Duties: Related experience in post market surveillance in a Medical Device or Pharmaceutical Industry preferred. Duties: May perform multiple functions within the postmarket surveillance department. Major responsibilities would include determining classification, review, and disposition of adverse events and medically related complaints for on-market products, including decisions on seriousness, reportability, and potential causality. Complete FDA MDR and other outside competent authority regulatory reports. Skills: If person has 0 - 2 years of course work or work experience they will be considered Person will be in-front of a computer for the entire day and will be successful if they can manage their time effectively and efficiently - must have organizational skills. Will be working with a complex product which is a heart pump in managing the day-to-day events and qualitative data related to product and patient information coming in from the field Must have excellent communication, organizational, attention to detail, and time management skills; will be using MS office suite with basic Excel working knowledge Education: 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 Note- Entry-level role - will accept fresh college graduates with internship or capstone project work someone with a Biomedical degree would be a good fit as this will allow for future opportunities Manager is open to someone with a background and/or degree in Technology or the Sciences