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Compliance & Regulatory Engineer

Job LocationStaffordshire
EducationNot Mentioned
Salary£25,000 - £30,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

You have the chance to join a globally recognised Specialist Manufacturer that are investing heavily in their site & have secured new business. As the Compliance & Regulatory Engineer you will be responsible for the compliance function onsite, taking ownership of the compliance & regulatory processes onsite.Client DetailsThis is a leading company that works with a market leading, premium customer base, & as such have been striving for operational excellence; investing in new equipment & driving efficiency at their Staffordshire site in order to be able to keep up with customer demands & increase site capacity.DescriptionAs the Compliance & Regulatory Engineer onsite, you will be a key member of the Quality department. This role will require you to be responsible for the compliance function, taking ownership of various compliance & regulatory processes as well as:Key Responsibilities:

  • Develop & manage the regulatory submissions
  • Responsible for the compliance & diligence of product technical files
  • Provide support & advice in Medical Device Regulations (MDR)
  • Lead & deliver projects with regulatory compliance
  • Liaise directly with regulated bodies
  • Review compliance & update existing technical files
  • Support in the implementation to become accredited to ISO15378
  • Identify areas of non-compliance & implement change
  • Support cross-functionally in external audits & lead internal audits
  • Communicate regulatory changes to the business
  • ProfileYou will be experienced within medical devices or related products, with a good understanding of compliance & regulatory management. As well as:
  • Ideally, Degree qualified or equivalent in a Science
  • Experience with product file management - MDD or MDR (ISO13485 or ISO15378)
  • Ideally, previous experience of regulatory submission, quality supplier auditing & quality management systems
  • Keen to become a technical specialist within regulatory projects
  • Strong communication across all levels
  • Understanding of electronic data management systems
  • Ideally experience with internal & external auditing
  • Job OfferCirca £25,000 - £30,000 + Additional Benefits Required skills
  • ISO
  • CI
  • MDR
  • compliance
  • quality
  • projects
  • process improvement
  • regulatory
  • auditing
  • Keyskills :
    ISO CI MDR compliance quality projects process improvement regulaty auditing

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