Head of Quality Assurance

3 weeks ago

Cambridge, Cambridgeshire, United Kingdom ProTech Recruitment Ltd Full time

Head of Quality and Regulatory Affairs

A leading healthcare technology company, ProTech Recruitment Ltd, is seeking a highly skilled and motivated Head of Quality and Regulatory Affairs to drive the organisation's innovative medical products through the regulatory approval process.

This individual will play a critical role in ensuring compliance with global quality standards, navigating complex regulatory landscapes, and bringing cutting-edge technologies to market.

Key Responsibilities:

  • Develop and Execute Regulatory Strategy: Lead the development and execution of the regulatory strategy for all products across key international markets.
  • Provide Regulatory Guidance: Ensure the team is up-to-date on global regulatory changes and provide training on regulatory requirements.
  • Oversee Submissions: Lead the preparation and submission of regulatory applications, including FDA approvals, UKCA, and CE marking.
  • Post-Market Compliance: Ensure that post-market surveillance activities comply with all regulatory requirements.
  • Manage External Relations: Serve as the key point of contact for communications with regulatory bodies, Notified Bodies, and other external stakeholders.

Requirements:

  • Demonstrable experience with successful regulatory submissions, including FDA, UKCA, and CE marking applications for in vitro diagnostics.
  • Strong knowledge of global regulatory requirements and standards.
  • Excellent communication and leadership skills.

  • Head of Quality Assurance

    2 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Marshall Full time

    Head of Quality OperationsMarshall is seeking an experienced Head of Quality Operations to join our team. As a key member of our organization, you will be responsible for delivering the Quality strategy for all Marshall activities across differing Business Lines, ensuring adherence to best practice protocols, regulation, and compliance, locally and...

  • Head of Quality Assurance

    2 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Marshall Full time

    Head of Quality OperationsMarshall is seeking an experienced Head of Quality Operations to join our team. As a key member of our organization, you will be responsible for delivering the Quality strategy for all Marshall activities across differing Business Lines, ensuring adherence to best practice protocols, regulation, and compliance, locally and...

  • Head of Quality Assurance

    3 weeks ago

    Cambridge, Cambridgeshire, United Kingdom The One Group Full time

    Role: Performance and Testing Manager / Head of TestSalary: $100,000Location: CambridgeThe One Group is seeking an experienced Performance and Testing Manager to lead their R&D team. The successful candidate will be responsible for ensuring the highest standards of quality and performance.Leadership and Strategy: Develop and implement testing strategies to...

  • Head of Quality Assurance

    4 days ago

    Cambridge, Cambridgeshire, United Kingdom The One Group Full time

    Role: Performance and Testing Manager / Head of TestSalary: 100kLocation: CambridgeThe One Group is seeking an experienced Performance and Testing Manager to lead their R&D team. The successful candidate will be responsible for ensuring the highest standards of quality and performance.Leadership and Strategy: Develop and implement testing strategies to...

  • Head of Quality Assurance

    3 weeks ago

    Cambridge, Cambridgeshire, United Kingdom The One Group Full time

    Role: Performance and Testing Manager / Head of TestSalary: $100,000Location: CambridgeThe One Group is seeking an experienced Performance and Testing Manager to lead their R&D team. The successful candidate will be responsible for ensuring the highest standards of quality and performance.Leadership and Strategy: Develop and implement testing strategies to...

  • Head of Quality Assurance

    3 days ago

    Cambridge, Cambridgeshire, United Kingdom The One Group Full time

    Role: Performance and Testing Manager / Head of TestSalary: 100kLocation: CambridgeThe One Group is seeking an experienced Performance and Testing Manager to lead their R&D team. The successful candidate will be responsible for ensuring the highest standards of quality and performance.Leadership and Strategy: Develop and implement testing strategies to...

  • Quality Assurance Manager

    3 weeks ago

    Cambridge, Cambridgeshire, United Kingdom University of Cambridge Full time

    Quality Assurance LeaderWe are seeking a highly skilled and experienced Quality Assurance Leader to join our team at the University of Cambridge. The successful candidate will be responsible for providing leadership on all issues related to GCP and ISO laboratory quality management system.Key Responsibilities:Provide leadership on GCP and ISO laboratory...

  • Quality Assurance Manager

    3 weeks ago

    Cambridge, Cambridgeshire, United Kingdom University of Cambridge Full time

    Quality Assurance LeaderWe are seeking a highly skilled and experienced Quality Assurance Leader to join our team at the University of Cambridge. The successful candidate will be responsible for providing leadership on all issues related to GCP and ISO laboratory quality management system.Key Responsibilities:Provide leadership on GCP and ISO laboratory...

  • Quality Assurance Manager

    3 weeks ago

    Cambridge, Cambridgeshire, United Kingdom University of Cambridge Full time

    Job Title: Quality Assurance LeaderWe are seeking a highly skilled and experienced Quality Assurance Leader to join our team at the University of Cambridge. The successful candidate will be responsible for providing leadership on all issues related to GCP and ISO laboratory quality management system.Key Responsibilities:Provide leadership on GCP and ISO...

  • Quality Assurance Manager

    3 weeks ago

    Cambridge, Cambridgeshire, United Kingdom University of Cambridge Full time

    Job Title: Quality Assurance LeaderWe are seeking a highly skilled and experienced Quality Assurance Leader to join our team at the University of Cambridge. The successful candidate will be responsible for providing leadership on all issues related to GCP and ISO laboratory quality management system.Key Responsibilities:Provide leadership on GCP and ISO...

  • Quality Assurance Specialist

    1 month ago

    Cambridge, Cambridgeshire, United Kingdom University of Cambridge Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at the University of Cambridge. The successful candidate will provide leadership on all issues related to GCP and ISO laboratory quality management system.Key ResponsibilitiesProvide guidance and advice to staff and customers on all aspects of GCP/ISO complianceOversee...

  • Quality Assurance Specialist

    1 month ago

    Cambridge, Cambridgeshire, United Kingdom University of Cambridge Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at the University of Cambridge. The successful candidate will provide leadership on all issues related to GCP and ISO laboratory quality management system.Key ResponsibilitiesProvide guidance and advice to staff and customers on all aspects of GCP/ISO complianceOversee...

  • Quality Assurance Lead

    1 month ago

    Cambridge, Cambridgeshire, United Kingdom University of Cambridge Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Lead to join our team at the University of Cambridge. The successful candidate will provide leadership on all issues related to Good Clinical Practice (GCP) and ISO laboratory quality management system.Key ResponsibilitiesProvide leadership on GCP and ISO laboratory quality management...

  • Quality Assurance Lead

    1 month ago

    Cambridge, Cambridgeshire, United Kingdom University of Cambridge Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Lead to join our team at the University of Cambridge. The successful candidate will provide leadership on all issues related to Good Clinical Practice (GCP) and ISO laboratory quality management system.Key ResponsibilitiesProvide leadership on GCP and ISO laboratory quality management...

  • Quality Assurance Specialist

    3 weeks ago

    Cambridge, Cambridgeshire, United Kingdom University of Cambridge Full time

    Job Title: CMDL Quality LeadWe are seeking a highly skilled and experienced Quality Lead to join our team at the Cancer Molecular Diagnostics Laboratory (CMDL) at the University of Cambridge.About the RoleThe successful candidate will provide leadership on all issues related to GCP and ISO laboratory quality management system, working closely with the...

  • Quality Assurance Specialist

    4 weeks ago

    Cambridge, Cambridgeshire, United Kingdom University of Cambridge Full time

    Job Title: CMDL Quality LeadWe are seeking a highly skilled and experienced Quality Lead to join our team at the Cancer Molecular Diagnostics Laboratory (CMDL) at the University of Cambridge.About the RoleThe successful candidate will provide leadership on all issues related to GCP and ISO laboratory quality management system, working closely with the...

  • Quality Assurance Manager

    3 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Optima Plus Recruitment Full time

    Job Title: Quality Assurance LeadCompany: Optima Plus RecruitmentLocation: CambridgeHours: Full-time, 37 hours per weekSalary: £40,743 - £41,578 paAbout Us: Optima Plus Recruitment is a leading recruitment agency dedicated to connecting talented individuals with rewarding employment opportunities. We specialize in matching skilled professionals with...

  • Quality Assurance Manager

    3 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Optima Plus Recruitment Full time

    Job Title: Quality Assurance LeadCompany: Optima Plus RecruitmentLocation: CambridgeHours: Full-time, 37 hours per weekSalary: £40,743 - £41,578 paAbout Us: Optima Plus Recruitment is a leading recruitment agency dedicated to connecting talented individuals with rewarding employment opportunities. We specialize in matching skilled professionals with...

  • Education Quality Assurance Specialist

    3 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Optima Plus Recruitment Full time

    Job Title: Quality Assurance LeadOptima Plus Recruitment is a leading recruitment agency dedicated to connecting talented individuals with rewarding employment opportunities.About the RoleWe are seeking a Quality Assurance Lead to drive high standards across our apprenticeship programmes. The successful candidate will support the Work Based Learning Manager...

  • Education Quality Assurance Specialist

    3 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Optima Plus Recruitment Full time

    Job Title: Quality Assurance LeadOptima Plus Recruitment is a leading recruitment agency dedicated to connecting talented individuals with rewarding employment opportunities.About the RoleWe are seeking a Quality Assurance Lead to drive high standards across our apprenticeship programmes. The successful candidate will support the Work Based Learning Manager...