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Quality and Regulatory Director

Job LocationYorkshire and Humberside
EducationNot Mentioned
SalaryCompetitive salary
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

The Director of Quality and Regulatory will be a key member of the site leadership team and will be required to build strong collaborative working relationships within the site and across LumiraDx operating network Responsible for all aspects of quality assurance, quality management, compliance and will lead pre-market quality and regulatory, including creation of regulatory files directly and in collaboration with the LumiraDx global regulatory team.Client DetailsLumiraDx is a medical technology company developing, manufacturing and marketing smart connected diagnostics and diagnostic-led care solutions. Founded in 2014 by entrepreneurs with a successful track record in building and scaling medical diagnostics and health IT businesses, the company has major operations in the UK and the USA, and is supported by a global sales network, LumiraDx is a high growth organisation.We are looking for proactive, experienced, focused and enthusiastic individuals who can make a significant contribution to the continued growth and success of our dynamic and forward-looking company.Description

  • The Director is responsible for assuring that every aspect of the quality system is suitably built and deployed and that the organisation understands, embraces and employs sound quality methodologies in all its work affecting product
  • Responsible for building, developing and maintaining a team of competent, committed and qualified Quality and Regulatory professionals who lead the Quality and Regulatory function to serve the business needs.
  • Create and manage key performance indicators for product quality, quality system performance and regulatory compliance and ensure dissemination and understanding of these across the organisation.
  • Establish and maintain the Quality System in compliance with applicable LumiraDx global process and to applicable international QS standards including ISO13485 and FDA CFR Part 820. Continually develop QMS to ensure it effectively and efficiently meets evolving business needs.
  • Manage operations quality activity across the site from incoming quality through manufacturing, packaging and final product release by ensuring the required competent resources and operational capacity is in place to meet business needs.
  • Manage supplier quality processes by establishing effective, efficient and compliant systems for both external and internal supplier base.
  • Engage collaboratively with global QA/RA functions and other LumiraDx sites to align on delivery of effective and efficient quality and regulatory service for the LumiraDx business
  • Site Management Representative - lead, achieve and maintenance of site registrations. Lead site preparation and management of external audits
  • Manage complaints and post market surveillance process in collaboration with global quality and regulatory partners.
  • Ensure effective QA/RA role as key member of a cross functional team in the introduction of new products and process validation. Lead execution of QA/RA deliverables.
  • Lead creation directly and in collaboration with Global Regulatory of product regulatory filings to ensure timely currency of product registrations.
  • Lead in creation of initiatives which represent the sites program of continuous improvement in quality and assist in development of appropriate action plans for the accomplishment of this agenda.Profile
  • Knowledge and experience of working to the appropriate quality and regulatory standards including ISO13485, FDA 21CFR Part 820.
  • Experience of managing and hosting regulatory agency and customer audits.
  • Proven and demonstrable experience of working in an IVD or medical device environment or similar with relevant experience in a significant QA/RA people management and leadership role.
  • Previous experience of managing product release of medical device/IVD products.
  • Previous experience of aligning global company quality requirements and implementing resulting systems in local sites
  • Previous experience of managing multiple sites
  • Experience of managing and developing a high performing team
  • Experience of manufacturing and post launch IVD or medical device activities
  • Scientific/Technical background with Masters degree in technical field.
  • Ability to use problem solving tools and methodologies.
  • Influence internal team and external parties to maximise success opportunities.
  • Knowledge and experience in High volume manufacturing
  • Continual Improvement mindset (PDCA, Kaizen, Six Sigma, Lean, Value Stream Mapping)
  • Job OfferCompetitive remuneration package and a challenging senior management level position in a rapidly growing organisation.Please note, if you wish to submit an application for this role, please consider the following information:PageGroup are our exclusive recruitment partner for this vacancy and all applications, whether internal or external, will be forwarded to them.If youre successful, you may be subject to all or some of the LumiraDx standard pre-employment checks. Required skills
  • Medical Devices
  • Regulatory Affairs
  • ISO13485
  • FDA 21CFR Part 820
  • Quality Director
  • Keyskills :
    Medical Devices Regulaty Affairs ISO13485 FDA 21CFR Part 820 Quality Direct

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