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Regulatory Engineer

Yolk Recruitment Ltd
Job LocationNewport, Gwent
EducationNot Mentioned
SalaryCompetitive salary
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

Regulatory EngineerDo you have experience working as a Regulatory Engineer within the medical field Do you have direct experience with medical devices Do you have a strong technical understanding This is what you’ll be doing You will be part of multiple product development teams supporting regulatory approvals and maintenance of clinical literature and clinical evaluation reports within the product’s technical files. This role also covers down-stream clinical coordinator activities, planning, managing and continued support for clinical trials:

  • Perform scientific literature search, review and analysis.
  • Identify complications and side-effects, including incident rates, for the intended use of devices
  • Support to the establishment, review and revision of the clinical evaluation per MDD/ MDR
  • Provide input into the risk management process per ISO 1497:2012, MDD and MDR as applicable.
  • Support CE marking and submission processes in general.
  • Provide input to device user and other training programmes based on instructions for use and risk analysis.
  • Provide support to chemical and biological compatibility.
  • Provide support during ISO 13485 certification.
    • The experience you’ll bring to the team
  • Experience within the Medical Device directive and particular standards associated with sterilisation and Biocompatibility of medical devices.
  • Computer literate- Microsoft office and online tools and databases.
  • Ability to analyse data.
  • Strong Technical Understanding.
  • Experience in Medical research preferred
    • And this is what you’ll get in return Competitive salary and benefits packageAre you up to the challenge Please contact Jessica Harmer, an Engineering Specialist today!Please apply with a CV and a cover letter outlining why you’re perfect for the role. We also have a referral scheme so if you know of someone who would be great for the role please get in touch.*Please note, whilst we do our best to contact all candidates, due to the high number of applications we receive we cannot guarantee this for every role. If you have not heard anything from us within 7 days of applying - then unfortunately you have been unsuccessful. Please keep an eye on our website for more opportunities.

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