Element Materials Technology

  • Medical Regulatory Affairs Engineer

    Job Locations UK-Worcestershire-Malvern
    ID
    2019-4439
  • Overview

    Element has an opportunity for a Medical Regulatory Affairs Engineer to join our rapidly expanding team. As a key member of the Advisory Services team, our new Engineer will provide expert advice and consultancy services to and will engage with customers to help them understand the compliance requirements for medical devices in respect to the medical devices directive / regulation and FDA requirements.

     

    The role will undertake Usability and Software assessments in accordance with IEC 62366-1:2015 and IEC 62304-1:2006/A1:2015, and provide guidance regarding the risk management file and technical documentation requirements of the applicable legislation.

    Responsibilities

    As a Medical Regulatory Affairs Engineer you will be involved with engaging with the client throughout the compliance process, providing support and guidance in many forms. As an expert in medical regulatory affairs you will be required to utilise your experience in many ways, including;

    • Producing Compliance Strategy documents
    • Performing Usability and Software assessments in accordance with IEC 62366-1:2015 and IEC 62304-1:2006/A1:2015
    • Providing guidance on medical regulatory requirements
    • Advising on best practise for product-focused risk management
    • Providing expert Technical Opinions
    • Conducting Compliance Reviews
    • Building relationships with customers by offering on-going support services, and supporting the medical products testing team

    Skills / Qualifications

    • Background in regulatory affairs in respect to electronic products (or similar)
    • Experience in undertaking software and usability assessments to the applicable standards
    • Detailed understanding of the EU and North American medical regulatory requirements as applicable to electrical/electronic devices and software
    • Electronics or similar qualification would also be advantageous

    Company Overview

    We are Element, one of the fastest growing testing, inspection, certification and calibration businesses in the world.

     

    We deliver critical services in Materials Testing, Product Qualification Testing, Certification, Device Calibration and Advisory Services to the Aerospace, Oil and Gas, Transportation, Industrials, Fire and Building product, Infrastructure and other leading sectors, where failure in service is simply not an option.

     

    Everything we do helps our customers to build better products; get their products to market on time; save them time and money; and minimize the risk associated with product development and production.

     

    Our mission is simple: to be the best testing partner in the world and together we strive towards a common vision of becoming the world’s most trusted testing partner.

     

    We have four values that we strive to live by every single day.

    • Safety - We keep our colleagues and visitors safe
    • Integrity - We act honestly and fairly to do the right thing
    • Excellence - We set new standards of excellence in everything we do
    • Partnership - We work together for the benefit of our customers

    When combined with our mission and vision, the ethos this creates, enables Element to deliver one thing. CERTAINTY.  We exist to help make certain that the materials and products we test, inspect, certify and calibrate for our customers are safe, quality, compliant and fit for purpose.

    Diversity Statement

    At Element, we always take pride in putting our people first. We are an equal opportunity employer that recognizes diversity and inclusion as fundamental to our Vision of becoming “the world’s most trusted testing partner”.

     

    All suitably qualified candidates will receive consideration for employment on the basis of objective work related criteria and without regard for the following: race, colour, age, religion, gender, national origin, disability, and/or protected veteran status, or other characteristics in accordance with the applicable governing laws.

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