Quality/ Lab/ Analyst, Product Surveillance

Kyyba - Burlington, MA

Full-time - Entry Level

Burlington, MA

Professional, Scientific, and Technical Services

About the position

The Quality/Lab Analyst in Product Surveillance is responsible for performing various functions within the post-market surveillance department, focusing on the classification, review, and disposition of adverse events and medically related complaints for on-market products. This role is crucial in ensuring compliance with regulatory requirements and maintaining product safety in the medical device or pharmaceutical industry.

Responsibilities

• Determine classification, review, and disposition of adverse events and medically related complaints for on-market products.
• Make decisions on seriousness, reportability, and potential causality of complaints.
• Complete FDA MDR and other outside competent authority regulatory reports.

Requirements

• Bachelor's degree in healthcare or science fields, or a 2-year degree with relevant experience in complaint handling investigations, medical device reporting, or product analysis.
• 0 - 2 years of related experience in post-market surveillance in the Medical Device or Pharmaceutical Industry preferred.

Nice-to-haves

• Degreed applicants without medical, scientific, or complaint handling experience may be considered if they possess suitable strengths for the position.

Benefits

• Dental insurance
• Health insurance
• Paid time off
• Vision insurance