• Lead Regulatory Engineer

    Location IE-Dublin 2 | DK-Ballerup | PL-Sekocin Nowy | IT-Carugate | NL-Arnhem | BE | ES-Barcelona
    Job ID
    2018-11392
    # of Openings
    1
    Job Category
    Advisory / Consultancy
  • Overview

    Lead Regulatory Auditor (IVD)

    Excellent salary and benefits package

    Location flexible

    As a global company, with more than 120 years expertise, UL certifies, validates, tests, verifies, inspects, audits and advises to make the world a safer, more secure, and more sustainable place to live. We clear the way for our customers to introduce the latest products, technological advances, and systems in an increasingly complex world so they can provide peace of mind to the market.

    Due to our ongoing growth and success, we are now seeking a Senior Auditor who will join the UL Medical Regulatory Team which is a likeminded and talented group of assessors with science, engineering and biotechnology backgrounds. And, since medical devices are some of the most regulated products in the world our new team member must have excellent knowledge of the medical device industry and specifically, Invitro-Diagnostics medical devices.

    Responsibilities

    • Have competent working knowledge of ISO 13485 and relevant medical device directive (MDD) and invitro diagnostic devices directive (IVDD).
    • 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.
    • Perform key development and support of UL’s Medical Device processes for future CE Regulations;
    • 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 required

    Qualifications

    • Degree in Microbiology, Biochemistry or equivalent experience
    • Be a registered (IRCA and/or RABQSA) Quality and/or Environmental and/or Occupational Health & Safety Lead Auditor is preferred.
    • Have competent working knowledge of ISO 13485 and invitro diagnostic devices directive (IVDD).
    • Be academically qualified in a recognized scientific/technological discipline.
    • Have had a minimum of five years recent and relevant industrial or business experience, of which at least three years have been devoted to 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.

    What We Offer

    At UL, our employees are our most valued asset. Your personal and professional development is important to us, and you can expect challenging work responsibilities, an attractive compensation package and exceptional career opportunities. More important than this are the great working conditions as part of a fantastic global team. If you like what you have read, we look forward to receiving your application.

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