Complaint / Regulatory Affairs Associate

Job Overview

Our client in the Ramsey area of NJ has an excellent HYBRID opportunity for a Complaint / Regulatory Affairs Associate!



  • Process Complaints and Medical Device Reports in a timely manner.
  • Utilize technical data obtained from all sources (historical complaints, SCAR, CAPA, etc.), and prepare complaint files in accordance with department procedure.
  • Assist colleagues in both United States and China to determine the root cause of failures, including CAPA, when applicable, as they relate to compliant activities.
  • Provide Quality/QSR and Regulatory Affairs support when directed by management.
  • Work with management to continuously evaluate and improve the complaint process.
  • In conjunction with management, the incumbent may make recommendations for the strategy for the defined function(s).
  • The incumbent will obtain guidance from management for matters concerning outside legal / regulatory consultants and/or regulatory agencies.
  • The incumbent has limited authority for changes made to Regulatory related documentation and activities.



  • Bachelor’s Degree.
  • 3-5 years in medical devices or other regulated industry.
  • Experience working within an ISO 13485:2016 quality system preferred.
  • Knowledge of FDA Medical Device Regulations.
  • Medical Device complaint handling knowledge and experience strongly preferred.
  • Work with Regulatory Affairs / Quality and other departments as needed to support complaint handling.
  • Work with management and interact with MRSZ Quality and R&D teams.
  • May interact with regulatory consultants when directed by management.
Job Detail
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