Analyst, Product Surveillance
Burlington, MA 
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Posted 1 day ago
Job Description
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
SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at nahr@spectraforce.com if you require reasonable accommodation.

 

Job Summary
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Associate Degree
Required Experience
0 to 2 years
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