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QARA Manager

Job LocationEast Midlands
EducationNot Mentioned
Salary60,000 - 70,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent , full-time Work from home

Job Description

QARA Manager Location: Can be based anywhere in Midlands or East Anglia (Remote working, occasional visits to labs an office, can be office based if would prefer)Salary up to £65,000A growing biotech business focussing on developing their novel product for detecting infectious disease are keen to bring on board someone with a varied skillset to manage their regulatory affairs, implement a QMS and manage projects.As this business is still within early development this role will initially focus on implementing the QMS, longer term this individual will get involved with regulatory responsibilities and will work on managing projects as the business develops. It is likelythis role will have responsibility for managing more junior staff focussing in a specific area within QA, RA or Projects.Responsibilities:

  • Establish, maintain and update a Quality Management System (QMS)
  • Manage the introduction of ISO 13485
  • Ensure all regulatory submissions are complete and compliant to enable registration of products in a timely manner
  • Effectively communicate to the CEO and senior management on quality issues (E.G. regular reports, periodic meetings)
  • Establish regular audits both internally and externally on key suppliers
  • Introduce a project-planning system within PBD such that all internal and external projects can be effectively managed
  • For R&D projects agree timescales and milestones with R&D colleagues and monitor progress
  • Liaise with external partners to agree project scope, milestones and costs which are then monitored
  • Establish regular Project Review Meetings with key stakeholders; make recommendations as to their relative priorities and recommend assigning resources to key projects
Requirements:
  • Strong experience within IVD product quality assurance, experience of ISO13485
  • Experience of regulatory affairs for registration of IVDs
  • Project Management experience would be advantageous but not essential
  • Capable of managing and leading a function that is expected to be much bigger in the future
If this sounds like an exciting next step for you then please do apply online, any questions can be directed to Kimberley at Jackson Hogg.

Keyskills :
Quality ManagementRegulatory AffairsIVDCE markingISO Certifications

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