Regulatory Affairs Labeling Specialist (19-00244) – CA – Irvine

Basic Qualifications:

  • minimum of a BA/BS in a scientific related field    
  • minimum of 3 years’ experience of medical device industry 
  • Regulatory affairs experience
  • Quality System experience (FDA, ISO, etc.)
  • Risk Management experience
  •  IDEs through to PMAs
  • Assessment of risks related to regulatory and development activities   
  • Computer literate; use of word processing, spreadsheets

Position Responsibilities:

  • Perform change order reviews
  • Completes PCNs (product change notices)
  • Support day to day regulatory activities
  • Gate keeps regulatory policies and procedures to assure compliance with FDA and international Quality System requirements.
  • Monitor and continuously improve regulatory process and product compliance.
  • Review quality and product documentation (DCR’s,   labeling, etc.) to ensure compliance with global regulatory agencies     
  • Record and complete incoming registration/re-registration documentation requests from the IDM and the FDA, research each request and send documentation as appropriate
  • Maintain technical files, design dossiers and all regulatory documentation in compliance with the Medical Device Directive and the Code of Federal Regulations.
  • Assure all regulatory documentation being sent to IDM and/or FDA is accurate and in compliance with regulatory requirements and Company procedures.
  • Communicate with all Company departments as needed to fulfill job requirements
  • May research, monitor or prepare semi-routine reports or analyses, summarize findings and make recommendations to solve administrative problems
  • Adheres to all environmental, health and safety SOP’s, policies and procedures, including any department specific requirements, Good Manufacturing Practices, 21CFR Part 820

Source: Job Diva – Job Listing

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