• Lead Regulatory Engineer / Lead Auditor (Life & Health medical devices)

    Location GB-Surrey | PL-Sekocin Nowy | DK-Ballerup
    Job ID
    2018-10404
    # of Openings
    1
    Job Category
    Engineering
  • Overview

    Lead Regulatory Engineer / Lead Auditor (Life & Health medical devices)

    UK or Europe based

    Excellent salary and benefits package

    At UL, we know why we come to work. Thousands of us around the world wake up every day with one common purpose - 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. We are proud that the work we do every day has a meaningful contribution to society. This helps us to sleep better at night, and we are confident that the millions of people we touch rest easier too.

    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, Medical Device Directive (MDD) or the In Vitro Diagnostic Directive (IVDD) and, where applicable, other regulatory requirements.

    Responsibilities

    Responsibilities:

     

    • 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.
    • 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

    Skills required:

    • 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.

    What We Offer:

    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 pleasant working conditions as part of a fantastic global team.

    A structured induction plan will support you to get trained for your new responsibilities. If you like what you have read, we are looking forward to receiving your application.

     

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