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Quality & Regulatory Manager – Medical Device - £45 – 47k pa + Bonus + Car Allowance + Additional Benefits

Job Reference: 10960-CC

Contract type:
Full Time


Location: Leeds, West Yorkshire

Kinetica has a superb opportunity for an experienced regulatory proffessional looking for the next step up into management to join a well-established and fast-expanding medical devices company in Leeds, West Yorkshire.

The main purpose of the role is to ensure  products are compliant with relevant GMP and Quality System standards, specifically FDA regulations, MDD/MDR and ISO13485. Further responsibilities of your role as Quality & Regulatory Manager will include:

  • Prepare and collate technical documentation
  • Provide QA and RA expertise to internal staff
  • Prepare and submit reports, as required and ensure that the company is in compliance
  • Ensure CAPA and complaints are completed
  • Line management responsibility
  • Lead the implementation of an ISO13485:2016 QMS
  • Manage Notified Body relationships and interactions with other regulatory / government bodies
  • Manage and authorise CAPAs
  • Conduct audits
  • Identify areas of non-compliance and work to rectify

To be considered for the position of Quality & Regulatory Manager it is essential to have solid working experience in  medical device  (class I, IIa and IIb) regulatory affairs . You must have an understanding of the EC Medical Device Directive / Medical Device Regulation requirements and FDA, as well as knowledge and experience of GMP and quality standards.  Excellent communication skills and a can-do attitude are essential for this role. 

Apply Now

Claire Collinson
Telephone: 0113 2617181

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