Be among the first 25 applicants
Get AI-powered advice on this job and more exclusive features.
Direct message the job poster from Cambridge Cognition
Job title: Quality & Regulatory Specialist
Department: Quality
Reporting to: Quality & Regulatory Manager
People Manager? No
Location: Hybrid (ideally based in our Bottisham office for 2 days per week)
Contract: Permanent
Working pattern: Full-time - 37.5 hours per week, Monday to Friday
Salary: £40,000 to £50,000 per annum, depending on experience
Who are Cambridge Cognition and what do we do?
We are a talented global team based in the UK, Canada and USA. Backed by over 30 years of scientific discovery and validation, Cambridge Cognition offers the end-to-end platform for CNS clinical trials. Our technologies are reliable in-clinic or at home for an improved patient experience and accelerated drug development.
We aim to make an extraordinary impact by improving the health of people worldwide with innovative assessments and digital biomarkers that provide researchers with precise measures of patients’ symptoms. We lead in CNS research and are broadening our impact across therapeutic areas.
Are you interested in working for a company whose main goal is to make a difference to the health of current and future generations, through the knowledge and experience of our passionate team?
Role Summary:
Due to an internal move, we are looking for a hands-on and adaptable Quality & Regulatory Specialist to join our team. This is a varied and fast-paced role with a dual focus on Regulatory Affairs and Quality Management System (QMS) support. You will gain broad exposure across regulatory submissions, audits, documentation management, and continual improvement initiatives while collaborating closely with multiple departments across the business.
What you’ll be doing:
Regulatory Affairs Support
* Assist with the preparation, submission, and maintenance of regulatory documentation (e.g., CE marking, UKCA, FDA 510(k), MHRA notifications, Technical Files).
* Monitor regulatory changes and advise on the impact to the business.
* Maintain accurate regulatory files and databases.
* Liaise with regulatory bodies and notified bodies as required.
Quality Management System (QMS) Support
* Support the maintenance and improvement of the QMS in line with ISO accreditations (13485, 27001, 9001) and clinical trial requirements.
* Assist with internal, supplier, and external audits/inspections.
* Help manage CAPA, non-conformance, and change control processes.
* Maintain controlled documents and records, ensuring timely updates.
* Support training activities related to quality and regulatory compliance.
Cross-Functional Collaboration
* Collaborate closely with R&D, Product, Clinical, Operations, Software, and other teams to ensure regulatory and quality requirements are met throughout the product lifecycle, including post-market activities.
* Actively contribute to problem-solving and process improvements across the business.
What we need from you:
* Bachelor’s degree in Life Sciences or a related field.
* Demonstrable, relevant experience in regulatory affairs or quality assurance, typically developed over a period of around 2 years, within the medical device, pharmaceutical, or clinical research industry.
* Knowledge of ISO 13485 and MDR regulations.
* Experience with document control systems and regulatory databases.
* Familiar with CAPA, non-conformance, and change control processes, with the ability to apply them effectively in a regulated environment.
* Knowledge of FDA and EMA regulations, and other relevant standards (ISO 9001, ISO 27001).
* Experience supporting audits and inspections.
* Familiarity with global product registration processes.
* Experienced in collaborating across cross-functional teams to achieve shared goals and ensure regulatory and quality requirements are met.
* Skilled at identifying opportunities for process improvements and implementing practical solutions.
* Have excellent communication and interpersonal skills, capable of influencing and collaborating with colleagues across diverse functions. Demonstrate strong problem-solving skills, managing multiple priorities while maintaining attention to detail and quality.
* Be highly organised, independent, and adaptable, able to prioritise effectively and manage competing tasks while supporting team goals and driving continuous improvement initiatives.
* Knowledge of requirements for data protection e.g. GDPR, HIPAA
* Auditing training for ISO standards
* Experience in Computer Systems Assurance (CSA)
Even if you don’t have all the experience we’ve listed, we’d still love to hear from you if you’re interested.
What we can offer you
* Be part of a driven team to achieve commercial success and make an extraordinary impact on global health
* Flexibility – 2 days a week at our office in Bottisham, just outside Cambridge; and 3 days from home
* 26 days annual leave per year plus bank holidays (including 3 days for Christmas break) with a holiday buy/sell scheme
* Generous pension with up to 6.5% company contribution
* Life assurance 2x base salary
* Employee Assistance Programme (EAP)
* Private Health Insurance - Bupa Insurance, Simply Health Cashback Scheme
Cambridge Cognition is an equal opportunities employer, we are committed to equality of opportunity for all employees and application from individuals are encouraged regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief, marriage, and civil partnerships.
Seniority level
* Entry level
Employment type
* Contract
Job function
* Quality Assurance
Referrals increase your chances of interviewing at Cambridge Cognition by 2x
Get notified about new Quality Specialist jobs in Cambridge, England, United Kingdom.
Quality Assurance and Contract Specialist
Huntingdon, England, United Kingdom 1 week ago
Cambridge, England, United Kingdom 1 day ago
Chatteris, England, United Kingdom 4 days ago
Quality Assurance and Contract Specialist
Huntingdon, England, United Kingdom 1 week ago
Cambridge, England, United Kingdom 2 months ago
Cambridge, England, United Kingdom 2 days ago
Cambridgeshire, England, United Kingdom 3 weeks ago
Birchanger, England, United Kingdom 2 weeks ago
St Neots, England, United Kingdom 1 week ago
Stevenage, England, United Kingdom 6 days ago
Christchurch, England, United Kingdom 1 month ago
St Neots, England, United Kingdom 1 week ago
Senior Staff Engineer, Automotive Customer Quality - Cambridge, UK
Cambridge, England, United Kingdom 1 day ago
Fulbourn, England, United Kingdom 1 week ago
Software Quality Assurance Team Leader (Fixed Term)
Cambridge, England, United Kingdom 1 week ago
Digitisation Technicians (Still Media) x 2
Duxford, England, United Kingdom 2 weeks ago
Cambridge, England, United Kingdom 1 week ago
Software Quality Assurance Team Leader (Fixed Term)
Cambridge, England, United Kingdom 1 week ago
Cambridge, England, United Kingdom 1 week ago
Data Quality Auditor, AGI Data Services - GT Quality
Cambridge, England, United Kingdom 1 day ago
Cambridge, England, United Kingdom 2 days ago
Data Quality Auditor, AGI Data Services - GT Quality
Cambridge, England, United Kingdom 3 days ago
Data Quality Auditor, AGI Data Services - GT Quality
Cambridge, England, United Kingdom 4 days ago
Stevenage, England, United Kingdom 4 days ago
Cambridge, England, United Kingdom 3 weeks ago
Cambridge, England, United Kingdom 1 month ago
Process Assurance Engineer - Software Quality
Cambridge, England, United Kingdom 1 week ago
Cambourne, England, United Kingdom 1 week ago
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr