• Lead Regulatory Engineer - In Vitro Diagnostic Directive (IVDD)

    Location US-IL-Northbrook | US-CA-Fremont | US-TX-Plano | US-WA-Camas | US-NY-Melville | US-GA-Atlanta
    Job ID
    # of Openings
    Job Category
  • Responsibilities

    As the successful candidate in this role, you will be a part of the UL Medical Regulatory Team, responsible for auditing some of the most regulated products in the world. Working with limited supervision, you will independently assist and support auditing and processing of manufacturer submissions to the ISO13485, the Medical Device Singe Audit program, and the In Vitro Diagnostic Directive (IVDD) and, where applicable, other regulatory requirements.


    Additionally, you will be responsible for: 

    • Identify and manage priorities as demonstrated by the ability to establish, track, and meet schedules for multiple projects while maintaining project quality.
    • Have a strong customer focus, flexibility
    • Demonstrate a confident, calm and decisive personality
    • Perform audits at the customer site lasting anywhere from 2 to 10 business days.
    • Perform contract review / project planning for technical file/design dossier evaluations and quality management system audits.
    • Assess technical file/design dossier and quality management systems against European Directives, essential requirements and latest common technical specifications.
    • Support regular quality system and technical audits, including unannounced audits.
    • Subject to training and qualification milestones, perform key CE certification responsibilities to support safe products to market.
    • Have competent working knowledge of ISO 13485 and relevant medical device directive (MDD) and invitro diagnostic devices directive (IVDD).
    • Participate in development and delivery of training materials to UL assessors.
    • Participate in the development of UL requirements and assessment methods. Integrate continuous improvement concepts into all aspects of the job.
    • Provide guidance and support to customers as required. Participate in client training and customer forums.
    • Overseas travel is expected


    • Bachelors Degree in Electrical Engineering from an accredited program plus 8 years of directly related work experience. 
    • Be a registered (IRCA and/or RABQSA) Quality and/or Environmental and/or Occupational Health & Safety Lead Auditor is preferred.
    • Have satisfactorily completed an RABQSA or IRCA approved training course in Quality and/or Environmental and/or Occupational Health & Safety System operation and auditing.
    • Have competent working knowledge of ISO 13485 and relevant medical device directive (MDD) and invitro diagnostic devices directive (IVDD).
    • Be academically qualified in a recognized scientific/technological discipline.
    • Proven ability in the practical application of quality assurance and/or medical or in vitro dialogistic devices.
    • Ability to travel, including a valid passport and driver’s license


    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed

    Connect With Us!