At a Glance
- Tasks: Lead compliance strategy and oversee regulatory submissions in a fast-growing diagnostics company.
- Company: Guilford Street Laboratories, an innovative UCL spin-out transforming disease diagnostics.
- Benefits: Competitive salary, contributory pension, life insurance, and optional private health insurance.
- Other info: Exciting opportunity for career growth in a collaborative and innovative environment.
- Why this job: Shape the future of medical diagnostics while building a dynamic compliance team.
- Qualifications: Degree in life sciences or related field with 3+ years in compliance or regulatory affairs.
The predicted salary is between 51750 - 63250 £ per year.
Head of Compliance and Regulatory Affairs | Up to £60,000 | London | Permanent Are you experienced in quality management and regulatory affairs within medical diagnostics or life sciences?
Would you like to shape compliance strategy within a fast-growing UCL spin-out?
Guilford Street Laboratories is seeking a Head of Compliance and Regulatory Affairs to oversee company certifications, regulatory clearances and international standards.
You will develop and maintain our Quality Management System and Information Security Management System, manage regulatory submissions and prepare the business for audits and inspections.
As the company expands, you will also build and lead an effective compliance team.
The role is primarily based across our offices in King’s Cross and Guilford Street, London, with monthly travel to Liverpool.
Maintain compliance with ISO 27001, ISO 9001, ISO 13485 and ISO 15189.
- Manage UKCA, CE and FDA 510(k) regulatory submissions.
- Oversee regulatory clearances for medical devices and services in the UK, EU and US.
- Deliver QMS and ISMS training, including staff inductions.
- Approve and monitor vendors against company quality standards.
- Oversee specialist quality and regulatory consultants.
- Build the compliance function as the business grows.
Guilford Street Laboratories is a fast-growing spin-out from University College London.
We develop and deliver innovative products and services within proteomics diagnostics, with the potential to transform how diseases are identified and managed.
- Contributory Pension scheme - auto enrolment
- Life Insurance- auto enrolment
- Optional Private Health Insurance - after qualifying period A degree or equivalent qualification in life sciences, quality management or a related subject.
- At least three years’ experience in compliance, QMS or regulatory affairs, ideally within proteomics, IVD or Sa MD.
- Knowledge of medical device regulations and regulatory approval processes.
- Permanent right to work in the UK.
- Further Lead Auditor training across relevant ISO standards and GCP would be welcomed.
If you are ready to take ownership of compliance and regulatory affairs within a growing diagnostics company, apply today
Regulatory Compliance and Legal in London employer: Guilford Street Laboratories
Guilford Street Laboratories is an exceptional employer, offering a unique opportunity to shape the IT function within a dynamic biotech environment in either Liverpool or London. With a strong commitment to employee growth and a collaborative work culture, we provide hybrid working arrangements that promote work-life balance while empowering you to lead transformative projects that directly impact scientific discovery. Join us to be part of a forward-thinking team where your contributions will be valued and your career can flourish.
Contact Details:
Guilford Street Laboratories Recruitment Team
