Total 2 Quality Assurance / Control job vacancies in Cambridgeshire, CB2 1UF

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.

Please see the attached Applicant Information Pack (combined Job Description and Person Specification) for key duties and responsibilities. Due to Home Office immigration rules, a full time permanent vacancy cannot be filled by individuals on a Student visa. Therefore, please be advised that if you are a Student visa holder, we will not be able to offer you a full time permanent contract unless you have:- applied for a Graduate visa- or you will have successfully completed your course and have applied for a Graduate visa before the anticipated start date of your employment- or the Trust has agreed that they will Sponsor you as a Skilled Worker and you will complete your studies within 3 months of the anticipated start date of employment. This vacancy will close at midnight on 24th November 2024 Interviews are due to be held on 9th December 2024 Benefits to you At Cambridge University Hospitals, we want to do all we can to support good working days. We offer development opportunities and a wide range of benefits, including on-site leisure facilities, shopping concourse and day nurseries. Our good work programme currently includes providing reduced cost Stagecoach bus travel to and from Cambridge University Hospital site. Park and Ride bus journeys between Babraham Road and Trumpington sites are free, as is the route to and from Cambridge train station and our hospitals. We also subsidise the cost of parking on site for eligible staff. On CUH campus, hot food is available 24/7 and at a reduced cost for colleagues. Recently we launched the first of our staff pod break spaces. Located in the Deakin Centre, we have a purpose-created colleague-only caf, with free tea and coffee, a break space and private outside area for colleagues to rest, refuel and recharge. Just one of the ways we are working hard to support good working days at CUH. CUH is committed to assisting employees in achieving a good work-life balance irrespective of role or personal circumstances. Flexible arrangements may include, but are not limited to, part-time working, job-share, term-time working and flexible start and finish times. Please note if you would like to discuss the required hours of this role further, you should approach the contact given. In some cases, alternative working hours will be considered. We welcome applications from the Armed Forces.