Building Regulations Principal Designer - Technical Lead

Laing O'Rourke; Manchester; Hybrid; GBP 150,000 - 200,000; Full time

Job summary

A public health regulatory agency in the UK is seeking an Innovative Devices Regulation Lead. This full-time position involves contributing to medical device regulations and engaging with various stakeholders. The ideal candidate has prior experience in IVD or medical device regulation. The role offers a hybrid working model with a minimum of 8 days on-site. Candidates must meet UK immigration and security requirements, with applications due by 18 December 2025.

Qualifications

• Previous experience in IVD or a medical device regulatory area.
• Experience in Regulatory Affairs, Quality Assurance, or Medical Affairs.
• Knowledge of current UK MDR and EU IVDR.

Responsibilities

• Contribute to the development and implementation of Medical Device Regulations.
• Lead engagement with internal and external stakeholders on regulatory policy.
• Establish mechanisms for enquiry handling for medical devices in the UK market.
• Organise continuous improvement in team ways of working.

Skills

Communicating & influencing

Managing a Quality Service

Delivering at Pace

Problem Solver

Adaptable

Education

Bachelor's degree in a scientific, engineering or medical discipline

Master's, PhD or equivalent in a scientific, engineering or medical discipline

Job description

Job Overview

We are looking for an Innovative Devices Regulation Lead to join the Innovative Devices Function within the Healthcare Quality and Access group of the Medicines and Healthcare products Regulatory Agency (MHRA). This is a full‑time permanent position based at 10 South Colonnade, Canary Wharf, London, E14 4PU. The role can only be worked in the UK. A flexible hybrid working model is in place, with a minimum of 8 days per month working on site (up to 12 days in some cases).

Key Responsibilities

• Contribute to the development and implementation of Medical Device Regulations as part of the MedTech Regulatory Reform programme, focusing on safer and more effective medical devices.


• Lead frequent engagement with internal and external stakeholders on all matters affecting regulatory policy and strategy development for Medical Devices.


• Establish effective mechanisms for enquiry handling for medical devices on the UK market to ensure patient safety.


• Organise continuous improvement in ways of working within the team, e.g. optimising documentation processing, creating SOPs and templates, and enabling automatic processes.

Person Specification

Experience

• Previous experience in IVD or a medical device regulatory area, including clinical, commercial, academic or policy settings.


• Experience developed through previous roles in Regulatory Affairs, Quality Assurance or Medical Affairs.


• Desirable: experience of developing, evaluating (including analytical validation, clinical studies, systematic reviews and evidence synthesis) and/or policy development.

Technical

• Bachelor's degree in a scientific, engineering or medical discipline.


• Desirable: Master's, PhD or equivalent in a scientific, engineering or medical discipline.


• Knowledge of current UK MDR and EU IVDR, and an understanding of the methodological approaches used to demonstrate IVD performance.

Behaviour and Strengths

• Communicating & influencing (A, I)


• Managing a Quality Service (A, I)


• Delivering at Pace (A, I)


• Problem Solver (I)


• Adaptable (I)

Application Process

• Applicants will complete an online application form with questions based on Behaviour, Experience, and Technical Success Profiles.


• Only completed applications will be considered; CVs are not reviewed during the initial stage
  
• Shortlisting will be based on lead criteria such as experience in IVD or medical device regulation, plus mandatory requirements.


• Interviews (and where appropriate, presentations or tests) will assess Behaviour, Experience, and Technical criteria.

Closing date: 18 December 2025. Shortlisting from 19 December 2025; interviews from 5 January 2026. Applicants may request disability‑related adjustments by contacting [e-mail].

All candidates will be subject to UK immigration requirements, Civil Service nationality rules and must pass a disclosure and barring security check, as well as animal‑rights and pro‑life activism checks. Basic personnel security standard checks are required for roles involving government assets.