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Manager, Regulatory Affairs

Company: Kelly
Location: Santa Ana
Posted on: June 22, 2022

Job Description:

Job title: Manager, Regulatory Affairs Location: Santa Ana, California
BASIC FUNCTIONAssist and coordinate the compiling, preparation and assembly of regulatory submission and support files for medical devices and in vitro diagnostics registration worldwide.
Such activities include: Technical File creation and preparation, Risk Management, FMEA, Essential Requirements, GSPR, outside references and various regulatory external and internal support as required.
SCOPEEnsure that requirements are met in all regulatory, compliance and registration functions as prescribed by the FDA's GMPs (QSR), ISO 13485, MDD 93/42, MDR 2017/745, IVDD 98/79/EC, IVDR 2017/746, ISO 14971, Brazilian GMPs, Health Canada MDR, Australian Medical Device regulations and regulatory requirements for product registrations where products are distributed worldwide.

  • Ensuring compliance of all processes and procedures to applicable standards.
  • Communicating with regulatory agencies, notified bodies, and competent authorities.
  • Prepare and maintain product registrations that include, but are not limited, to the following:
  • Substantial changes and new product submissions
  • Renewal of Technical Files and communication with corresponding Agents (EU AR, China, etc.)
  • US FDA 510(k) Premarket Notifications
  • US FDA Drug Master Files and annual updates
  • Technical Files for EU and EU AR
  • Oversee, manage and assist with the following activities:
  • Internal/External and Customer Audits
  • Change assessment to product design, specifications, or product manufacturing processes
  • New Product Committee (NPC) Design Control
  • Product Recalls
  • Field safety corrections
  • Mandatory Device Reporting (MDR), Mandatory Problem Reporting (MPR), Vigilance Reporting (EU), Adverse Events Reporting (Worldwide)
  • Writing and/or revising regulatory related standard operating procedures
  • Preparing monthly reports on product registration status
  • Provide regulatory approval for the following, but not limited to:
  • Non-conformances / CAPA's
  • Quality Planning
  • Risk Assessments
  • Document Changes (SOPs, labeling, etc.)
  • Assist in the assessment of Technical Department (R&D) activities that include, but are not limited to, the following:
  • MDR, MPR and/or vigilance investigations for complaints
  • Risk Management File Review and revision based upon complaint
  • Maintain all applicable licensing including: Local, State and National Regulatory licensing and registration renewals
  • Import/Export Permits

Keywords: Kelly, Santa Ana , Manager, Regulatory Affairs, Executive , Santa Ana, California

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