Product Surveillance Analyst

Intellectt - Burlington, MA

Full-time - Entry Level

Burlington, MA

Professional, Scientific, and Technical Services

About the position

The Product Surveillance Analyst role is focused on post-market surveillance activities for medical devices, particularly heart pumps. This entry-level position is suitable for recent graduates with relevant educational backgrounds or internship experiences in biomedical fields. The analyst will be responsible for reviewing and classifying adverse events and complaints related to on-market products, ensuring compliance with regulatory reporting requirements, and collaborating with cross-functional teams to maintain product quality and patient safety.

Responsibilities

• Determine classification, review, and disposition of adverse events and complaints related to on-market products.
• Make decisions on the seriousness, reportability, and potential causality of adverse events.
• Complete regulatory reports, including FDA Medical Device Reports (MDR) and other outside competent authority regulatory reports.
• Work with complex products (heart pumps) and manage qualitative data coming from the field.
• Collaborate with cross-functional teams, ensuring timely and accurate reporting of events.

Requirements

• Four-year degree, preferably in healthcare or science fields, OR two-year degree with relevant experience in complaint handling, medical device reporting, or product analysis.
• Excellent organizational skills with the ability to manage time effectively and efficiently.
• Strong communication, attention to detail, and time management skills.
• Familiarity with MS Office Suite (especially basic Excel).
• Ability to manage multiple tasks simultaneously and work in a fast-paced environment.

Nice-to-haves

• Background in post-market surveillance in a medical device or pharmaceutical industry preferred, but not required.
• Candidates who have managed jobs or extracurriculars alongside their academic studies are preferred.

Benefits

• Potential for extension or conversion to full-time after contract period.