Job Overview Our client in the Ramsey area of NJ has an excellent HYBRID opportunity for a Complaint / Regulatory Affairs Associate! Responsibilities: 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. Requirements: 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 Shortlist Apply Now Apply with Linkedin Never pay anyone for job application test or interview. Related Jobs (10) Senior Financial Analyst – Delegated Underwriting Authority Enterprises (DUAE) Full Time Financial Analyst – Property and Casualty Full Time Associate Director – Insurance Linked Securities Group (ILS Group) Full Time Sr. SAP FICO / COPA Business Analyst Full Time SAP Systems Analyst – Warehouse Management Systems Full Time UI/UX Designer Full Time Project Manager Full Time Ecommerce Data Analyst Full Time DevOps Engineer Full Time Sr. Systems Analyst Full Time Contact You accepts our Terms and Conditions