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Regulatory Compliance Specialist

2 months ago

Calabasas, California, United States Medical Device Company Full time
Job Overview

The role of a Regulatory Compliance Specialist involves a comprehensive understanding of EN 13485/ ISO 13485, MDSAP, CE MDR Medical Device Class I and Class II, along with all relevant standards applicable to our offerings. The responsibilities include:

  • Evaluating and documenting supplier qualifications
  • Monitoring Return Merchandise Authorizations (RMAs)
  • Tracking and categorizing complaints
  • Assessing on-time delivery and frequency of complaints
  • Conducting post-market surveillance, gathering customer feedback, and preparing vigilance reports
  • Overseeing RMAs and complaints
  • Managing medical and clinical trial publication documentation
  • Creating Standard Operating Procedure (SOP) flowcharts and Quality Test Documents
  • Generating Engineering Change Notices (ECNs)
  • Maintaining up-to-date Design History Files
  • Keeping Device Master Records current
  • Ensuring document control files are updated
  • Interfacing with notified bodies and ISO 13485, MDSAP, and CE auditors
  • Scheduling audits
  • Generating and maintaining Risk Management documents for each product line
  • Collaborating with European representatives
  • Working with management on Adverse Event Reporting
  • Conducting internal audits and managing documentation
  • Assisting in the editing, copying, sending, notarization, and apostille services for compliance documentation
  • Performing additional quality control tasks as assigned
  • Addressing unexpected tasks as they arise

Job Type: Full-time, In-person, 8:00 AM to 5:00 PM

Company Overview

Micro Medical Devices Inc. is a cutting-edge medical device company specializing in ophthalmic instruments. Our mission is to provide eye care health service devices to diverse populations worldwide, supporting medical professionals and mission groups in delivering essential eye care services.