Head of Quality and Regulatory

6 hours ago


Cambridge, United Kingdom ProTech Recruitment Ltd Full time

Head of Quality and Regulatory Affairs

A fast growing healthcare technology company is looking for a highly skilled and motivated Head of Quality and Regulatory Affairs to join their team. This individual will play a critical role in guiding the organisation's innovative medical products through the regulatory approval process, ensuring compliance with global quality standards. This is an exciting opportunity for someone who is passionate about navigating complex regulatory landscapes to bring cutting-edge technologies to market.

You must have demonstrable experience with successful regulatory submissions, including FDA, UKCA, and CE marking applications for in vitro diagnostics.

Role Overview

Lead Regulatory Strategy: Develop and execute 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 train team members 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 reimbursement entities.Additionally, the Head of Quality will manage the company's quality systems, including:

Achieve ISO13485 Certification: Lead the process to gain and maintain ISO13485 certification, ensuring full compliance with quality standards.
Quality Management System (QMS): Oversee the company's QMS, ensuring that all staff are trained on and adhere to quality procedures.
Audit Leadership: Lead both internal and external audits to ensure ongoing compliance.

This is an exceptional opportunity to drive the regulatory and quality functions of a company at the forefront of healthcare innovation. Ideal candidates will be passionate about bringing life-changing products to market while ensuring the highest regulatory and quality standards.

Please note: We are unable to accept applicants who require sponsorship



  • Cambridge, United Kingdom CV-Library Full time

    Head of Quality and Regulatory Affairs A fast growing healthcare technology company is looking for a highly skilled and motivated Head of Quality and Regulatory Affairs to join their team. This individual will play a critical role in guiding the organisation's innovative medical products through the regulatory approval process, ensuring compliance with...


  • Cambridge, United Kingdom ProTech Recruitment Ltd Full time

    Head of Quality and Regulatory AffairsA fast growing healthcare technology company is looking for a highly skilled and motivated Head of Quality and Regulatory Affairs to join their team. This individual will play a critical role in guiding the organisation's innovative medical products through the regulatory approval process, ensuring compliance with global...


  • Cambridge, United Kingdom ProTech Recruitment Ltd Full time

    Head of Quality and Regulatory Affairs A fast growing healthcare technology company is looking for a highly skilled and motivated Head of Quality and Regulatory Affairs to join their team. This individual will play a critical role in guiding the organisation's innovative medical products through the regulatory approval process, ensuring compliance with...

  • Deputy Head of Quality

    8 months ago


    Cambridge, United Kingdom Cambridgeshire and Peterborough NHS Foundation Trust Full time

    Please refer to the attached job description and person specification for full details of responsibilities To provide strong and visible leadership across the Collaboratives six Trusts, in developing and implementing policies and approach for a single unified quality assurance framework that provides compliance monitoring and reporting to the Collaborative...


  • Cambridge, Cambridgeshire, United Kingdom ProTech Recruitment Ltd Full time

    Head of Quality and Regulatory AffairsProTech Recruitment Ltd is seeking a highly skilled and motivated Head of Quality and Regulatory Affairs to join their team. This individual will play a critical role in guiding the organisation's innovative medical products through the regulatory approval process, ensuring compliance with global quality standards. This...


  • Cambridge, United Kingdom Biochrom Full time

    Biochrom is part of Harvard Bioscience (HBIO), a global business providing life science, laboratory apparatus worldwide. Reporting to Biochrom QRA Manager, the **Quality and Regulatory Affairs Specialist** (QRA Specialist) supports our _in-vitro_ diagnostic product registrations, timely undertaking of post market surveillance as well as monitoring...


  • Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Full time

    Job Description: Quality Assurance and Regulatory Affairs ExpertCompany Overview:Newton Colmore Consulting is a leading consulting firm in the medical devices industry, providing expert advice on regulatory affairs and quality assurance. We are committed to delivering high-quality services that meet the needs of our clients, and we are seeking a talented...


  • Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Full time

    Job Title: Regulatory Affairs and Quality Assurance ProfessionalAbout the Role:We are seeking a skilled Regulatory Affairs and Quality Assurance Professional to join our team at Newton Colmore Consulting. As a key member of our R&D team, you will play a vital role in ensuring compliance with FDA 510k, ISO 13485, and FDA 21 CFR Part 820 standards for new...


  • Cambridge, Cambridgeshire, United Kingdom Gilead Sciences, Inc. Full time

    Job Description:Gilead Sciences, Inc. is seeking a highly experienced professional to lead our Global Regulatory Affairs Operations team. As a key member of the organization, you will be responsible for developing and implementing strategic plans to improve regulatory processes, ensure compliance, and drive business excellence.Key Responsibilities:Lead the...


  • Cambridge, Cambridgeshire, United Kingdom 52North - creators of Neutrocheck® Full time

    We are 52North, creators of Neutrocheck®, a med-tech company striving to transform patient experiences and set new industry standards through innovative technology.This exciting opportunity requires a Regulatory Compliance Expert to oversee our QMS, ensure adherence to regulations, and develop effective quality processes.ResponsibilitiesLeading the...


  • Cambridge, United Kingdom University of Cambridge Full time

    Continuing education is currently one of the most exciting, prominent, and fastest moving fields in UK-based and global higher education. The University of Cambridge Institute of Continuing Education (ICE) is an established leader in the field, tracing its roots back to 1873. We deliver high quality and distinctive educational programmes for adult learners,...


  • Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Ltd Full time

    Newton Colmore Consulting Ltd is a leading recruitment specialist in Medical Devices, Science, and Biotech. We are looking for a talented Regulatory Affairs and Quality Assurance Assistant to join our team. This role involves supporting the Quality Assurance and Regulatory Affairs Manager in ensuring compliance with industry standards and...


  • Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Ltd Full time

    **Job Overview**We are seeking a highly skilled Regulatory Affairs and Quality Assurance Assistant to join our dynamic team at Newton Colmore Consulting Ltd. Based in Cambridge, this role offers the opportunity to work with a growing medical devices company, providing quality assurance and regulatory affairs advice on the creation of new products and...


  • Cambridge, Cambridgeshire, United Kingdom Vectura Group Full time

    Regulatory LeadershipVectura Group, a global leader in inhaled therapies and drug-device combination products, seeks a seasoned Regulatory Affairs Manager to drive the success of our medical device and DDCP regulatory activities.Regulatory Expertise: Lead regulatory activities across Vectura Group, specializing in medical devices and DDCPs, to support...


  • Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Ltd Full time

    About the RoleWe are seeking a highly skilled Regulatory Affairs and Quality Assurance Professional to join our team at Newton Colmore Consulting Ltd. As a key member of our medical devices recruitment team, you will be responsible for providing quality assurance and regulatory affairs advice to our clients.The ideal candidate will have a strong background...


  • Cambridge, Cambridgeshire, United Kingdom ProTech Recruitment Ltd Full time

    Head of Regulatory ComplianceA fast-growing healthcare technology company is seeking a highly skilled Director of Quality Assurance and Compliance to drive regulatory compliance across international markets. This individual will play a pivotal role in guiding the organization's innovative medical products through the regulatory approval process, ensuring...


  • Cambridge, Cambridgeshire, United Kingdom 52North - creators of Neutrocheck® Full time

    About 52North, we're a med-tech company dedicated to revolutionizing healthcare journeys worldwide.We're seeking a Quality Management Specialist to join our collaborative team. This role involves managing our QMS on a day-to-day basis, supporting regulatory activities, and contributing to product technical and quality documentation.Key...

  • Deputy Head

    6 months ago


    Cambridge, United Kingdom University of Cambridge Full time

    The University of Cambridge is one of the world's foremost universities and a renowned centre for research, education and scholarship. Their sustained pursuit of academic excellence is built on a long history of world-leading teaching and research within a distinctive collegiate system. Today, the University comprises 150 faculties and departments and is a...


  • Cambridge, United Kingdom CV-Library Full time

    Quality Assurance and Regulatory Affairs Lead Location: Hybrid - need to be able to attend the Cambridge site Hours: 37.5 hours Salary: Competitive and will depend on experience Reed Scientific have partnered with an industry leading Biotech at the forefront of diabetes research. My client has an immediate requirement for someone to lead the quality and...


  • Cambridge, Cambridgeshire, United Kingdom Reed Engineering Full time

    Quality Assurance and Regulatory Affairs LeadReed Engineering has partnered with an industry leading Biotech at the forefront of diabetes research. My client has an immediate requirement for someone to lead the quality and regulatory projects and functions. You will maintain and improve robust quality management systems and ensure adherence to regulatory...