Quality Assurance Regulatory Affairs Manager

7 days ago

Great Abington, United Kingdom Cure Talent Full time
Job Description

Cure Talent is delighted to be exclusively partnered with an innovative early-stage Medical Device company specialising in Female Health Diagnostics. Their goal is to pioneer advancements in early detection and treatment options for gynaecological cancers, developing cutting-edge technologies and healthcare solutions that enhance outcomes and save lives.


This is a hybrid role offering flexible home and site working arrangements.


As they embark on this journey, we have an exciting opportunity for a QARA Manager to play a pivotal role in implementing and driving the development & maintenance of their Quality Management System (QMS). In this brand new role you will support in achieving UKCA Marking and will also support the transition towards CE Marking and FDA approval, working closely with internal teams to ensure regulatory compliance.


To be successful in this role we are looking for an experienced Medical Device Quality Assurance professional with proven experience in the implementation and subsequent management and development of QMS. You will have experience of working within a smaller, growing organisation and understand the nuances of the early-stage development process and ideally have experience in supplier selection, management and auditing. A 13485 Lead Auditor qualification is highly advantageous for this role.


Responsibilities:

  • Lead the implementation, management, and continuous improvement of the Quality Management System
  • Oversee the UKCA marking process, ensuring readiness for audits and regulatory milestones
  • Develop and manage supplier selection and auditing processes
  • Support regulatory strategies including preparation for CE Marking and future FDA submissions
  • Ensure compliance with relevant regulations and support post-market activities


Qualifications:

  • Proven experience in a senior QA or QARA role within Medical Devices
  • Experience & knowledge of the implementation of a 13485 QMS
  • Strong knowledge of UKCA and CE marking processes (understanding of FDA regulations is highly advantageous)
  • Experience in supplier management and auditing
  • Knowledge and experience of IVD’s and the subsequent regulations is highly advantageous


If you are a driven and innovative professional ready to make a significant impact in a growing company, we would love to hear from you. Get in touch with Kris Holmes at Cure Talent today

  • Quality Assurance Regulatory Affairs Manager

    2 weeks ago

    great abington, United Kingdom Cure Talent Full time

    Cure Talent is delighted to be exclusively partnered with an innovative early-stage Medical Device company specialising in Female Health Diagnostics. Their goal is to pioneer advancements in early detection and treatment options for gynaecological cancers, developing cutting-edge technologies and healthcare solutions that enhance outcomes and save lives....

  • Quality Assurance Regulatory Affairs Manager

    2 weeks ago

    Great Abington, United Kingdom Cure Talent Full time

    Cure Talent is delighted to be exclusively partnered with an innovative early-stage Medical Device company specialising in Female Health Diagnostics. Their goal is to pioneer advancements in early detection and treatment options for gynaecological cancers, developing cutting-edge technologies and healthcare solutions that enhance outcomes and save lives.This...

  • Quality Assurance Regulatory Affairs Manager

    6 days ago

    Great Abington, United Kingdom Cure Talent Full time

    Cure Talent is delighted to be exclusively partnered with an innovative early-stage Medical Device company specialising in Female Health Diagnostics. Their goal is to pioneer advancements in early detection and treatment options for gynaecological cancers, developing cutting-edge technologies and healthcare solutions that enhance outcomes and save lives.This...

  • Quality Assurance Regulatory Affairs Manager

    2 weeks ago

    Great Abington, UK, Cambridge, United Kingdom Cure Talent Full time

    Cure Talent is delighted to be exclusively partnered with an innovative early-stage Medical Device company specialising in Female Health Diagnostics. Their goal is to pioneer advancements in early detection and treatment options for gynaecological cancers, developing cutting-edge technologies and healthcare solutions that enhance outcomes and save lives.This...

  • Quality Assurance Specialist

    3 weeks ago

    Great Linford, United Kingdom Quality Personnel Full time

    We are seeking a Quality Control Engineer to join our team at Quality Personnel, a leading recruitment agency in Milton Keynes. As a Quality Control Engineer, you will be responsible for ensuring the quality of our products and services.Key Responsibilities:Oversee and update the Quality Management System to ensure compliance with regulatory...

  • Quality Assurance Specialist

    2 weeks ago

    Great Linford, United Kingdom Quality Personnel Full time

    We are seeking a Quality Assurance Specialist to join our team at Quality Personnel. The successful candidate will be responsible for ensuring the quality of products and services provided by vendors, including incoming inspection. The role will also involve some physical work to unpack and inspect products and materials.The ideal candidate will have...

  • Quality Assurance Specialist

    2 months ago

    Great Linford, United Kingdom Quality Personnel Full time

    Quality Control Co-ordinator Job DescriptionWe are seeking a highly skilled Quality Control Co-ordinator to join our team at Quality Personnel. As a Quality Control Co-ordinator, you will play a crucial role in ensuring the quality of our products and services meets the highest standards.Key Responsibilities:Conduct incoming inspections to ensure products or...

  • Quality Assurance Specialist

    2 months ago

    Great Linford, United Kingdom Quality Personnel Full time

    Quality Control Co-ordinator Job DescriptionWe are seeking a highly skilled Quality Control Co-ordinator to join our team at Quality Personnel. As a Quality Control Co-ordinator, you will play a crucial role in ensuring the quality of our products and services meets the highest standards.Key Responsibilities:Conduct incoming inspections to ensure products or...

  • Quality Assurance Coordinator

    1 month ago

    Great Linford, United Kingdom Quality Personnel Full time

    Quality Control Co-ordinator Job DescriptionWe are seeking a highly skilled Quality Control Co-ordinator to join our team at Quality Personnel. As a Quality Control Co-ordinator, you will play a crucial role in ensuring the quality of our products and services meets the highest standards.Key Responsibilities:Conduct incoming inspections to ensure products or...

  • Quality Assurance Coordinator

    1 month ago

    Great Linford, United Kingdom Quality Personnel Full time

    Quality Control Co-ordinator Job DescriptionWe are seeking a highly skilled Quality Control Co-ordinator to join our team at Quality Personnel. As a Quality Control Co-ordinator, you will play a crucial role in ensuring the quality of our products and services meets the highest standards.Key Responsibilities:Conduct incoming inspections to ensure products or...

  • Senior Medical Device Quality Assurance Manager

    1 week ago

    Little Abington, United Kingdom Cure Talent Ltd Full time

    Cure Talent Ltd is delighted to be partnering with an innovative early-stage Medical Device company specialising in Female Health Diagnostics. Their mission is to pioneer advancements in early detection and treatment options for gynaecological cancers, developing cutting-edge technologies and healthcare solutions that enhance patient outcomes and save...

  • Quality Assurance Specialist

    3 weeks ago

    Great Linford, United Kingdom Quality Personnel Services Ltd Full time

    Job Title: Quality Assurance SpecialistWe are seeking a skilled Quality Assurance Specialist to join our team at Quality Personnel Services Ltd. The successful candidate will be responsible for ensuring the quality of products and services provided by vendors.Key Responsibilities:• Conducting audits to ensure compliance with ISO standards• Reviewing...

  • Senior Quality Assurance Contractor

    5 months ago

    Great Yarmouth, United Kingdom Petrofac Full time

    **_Petrofac is seeking a Senior Quality Assurance - _**_Contractor for 6 _** **_months based in Great Yarmouth, UK._** **_ The role is outside IR35 and we invite Limited Companies to engage._** **Scope of Services**: - Maintain the Contract Quality Management System for ENI Hewett contract. - Maintain and monitor each contract team’s progress against...

  • Quality Assurance Manager

    3 weeks ago

    Great Billington, United Kingdom Industrious Recruitment Full time

    Quality Systems LeaderIndustrious Recruitment is seeking a Quality Systems Leader to support their business in the Food Industry. The ideal candidate will have experience with BRCGS, ISO 45001, ISO 14001, and ISO 9001, and will be responsible for maintaining alignment with the Quality Management System to support ongoing certification.Maintain alignment with...

  • Quality Assurance Manager

    2 weeks ago

    Great Dunmow, United Kingdom HR GO Recruitment Full time

    Quality Assurance Manager OpportunityThis is an excellent chance to develop your current quality systems experience and support the current quality manager when they retire. The role will look after quality systems covering a diverse range of engineering disciplines, including aerospace & Medical parts manufacture, sheet metal and construction metalwork.Key...

  • Quality Assurance Specialist

    1 month ago

    Great Linford, United Kingdom Quality Personnel Services Ltd Full time

    We are recruiting for a Quality Control Engineer to join our team at Quality Personnel Services Ltd in Milton Keynes. The successful candidate will work on ensuring products or services provided by vendors meet our high standards. Key responsibilities include:• Conducting audits to verify compliance with ISO standards• Reviewing technical drawings to...

  • Quality Assurance Specialist

    1 month ago

    Great Linford, United Kingdom Quality Personnel Services Ltd Full time

    We are recruiting for a Quality Control Engineer to join our team at Quality Personnel Services Ltd in Milton Keynes. The successful candidate will work on ensuring products or services provided by vendors meet our high standards. Key responsibilities include:• Conducting audits to verify compliance with ISO standards• Reviewing technical drawings to...

  • Quality Assurance Specialist

    3 weeks ago

    Great Yarmouth, Norfolk, United Kingdom Swift Temps Ltd Full time

    Quality and Regulatory EngineerMetal Fabrication Business (Stainless Steel)We are seeking an experienced Quality and Regulatory Engineer to lead integration efforts across quality processes within our stainless steel fabrication business. You will be the focal point for all audits and ensure health and safety remains the top priority, so our team returns...

  • Quality Inspector/Co-ordinator

    3 weeks ago

    Great Linford, Buckinghamshire, United Kingdom Quality Personnel Full time

    We are recruiting for Quality Control Engineer for our customer based in Milton Keynes Enhanced holidays * Pension Above average Excel skills * including incoming inspection. * Overseeing and updating Quality Management System * Reviewing processes to improve productivity, quality and reduce costs. * Write compliance/regulatory documentation for...

  • Regional Quality Assurance Administration Partner

    5 months ago

    Great Linford, United Kingdom Excelcare Holdings Full time

    **Regional Quality Assurance Administration Partner** **£32,000 plus 2.5k car allowance. Mon-Fri, 8.00am-5.00pm.** Excelcare is a privately owned nursing and care home provider established for over 34 years. Our London and Milton Keynes region comprises 10 care homes. We have an excellent opportunity for a Regional Quality Assurance Administration Partner...