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Postmarket Surveillance Analyst II

Burlington, Massachusetts 01803

Category: Professional Job Number: 17727

 

Voca has an immediate opening available for a Product Surveillance Analyst in Burlington, MAInterested candidates will forward current resume to Chad Miller at cmiller@myvoca.com and call 952-303-8107. Thanks!

 

Position Details 

Job Description:

  • On a daily basis, reviews and investigates all incoming customer comments related to product quality and patient safety.
  • Oversees the input of information documenting same into the database.
  • Position will feel like data entry, but it isn’t very simple. Takes risk events, if compliant, determines reportability to other governing agencies.
  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.


Qualifications

  • Preference for Health/Science Bachelor Degree. Open the Nurses (only candidates who would be considered with an Associate Degree).
  • Looking for more of an analyst rather than coordinator.
  • Time management skills essential for this role.
  • Two or more years of complaint handling experience in a closely related field in the medical device and/or pharmaceutical industry or equivalent preferred.
  • The demonstrated ability to understand and comply with applicable U.S. Food & Drug Administration (FDA) regulations and Company operating procedures, processes, policies and rules is essential.
  • Working knowledge of relevant Codes of Federal Regulations (CFRs) and International Organization for Standardization (ISO) regulations is a bonus but not required.

 

Voca: The Spirit of Work

IND- CM

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