• Staff Engineer

    Location GB-Surrey
    Job ID
    2018-11273
    # of Openings
    1
    Job Category
    Other
  • Overview

    Product Reviewer

    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 number of Product Reviewers who will join the UL Medical Regulatory Team which is a likeminded and talented group of which many hold a science, engineering and biotechnology background. And, since medical devices are some of the most regulated products in the world our new team members will be involved primarily with the assessment of medical device manufacturer’s technical documentation and you may also be involved in supporting QMS audits to ISO13485 and MDSAP.

    Responsibilities

     

    Within the framework of our highly regulated Notified Body you will perform conformity assessment activities for manufacturers seeking CE-marking, namely:

    • Review of manufacturer’s technical documentation
    • Support QMS audits and unannounced audits as technical expert
    • Conduct contract reviews / project planning
    • Support Certificate Decision Makers by making certification recommendations
    • Support Notified Body regulatory and compliance activities (e.g. training, Competent Authority audits)
    • Guidance and support of customers as permitted within the regulatory framework
    • Participation in client training and customer forums

    Qualifications

     

    • At least a Bachelor’s or Master’s degree, or PhD (in engineering or other relevant science)
    • BSc, Master’s degree (or equivalent qualification) in a discipline relevant to medical device manufacture and use.
    • Proven ability working with medical devices (or related health/science field), and/or regulatory affairs
    • Demonstrable experience and knowledge of design, development, manufacturing of medical devices Demonstrable experience and knowledge of product standards
    • Direct experience working with the medical device regulations
    • Experience in the application of design control, product testing, risk management and performance or clinical evaluation of medical devices.
    • Auditing experience is ideal but not essential
    • Strong communication and project management skills
    • Fluent English language skills essential and other EU language skills desirable not essential

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