Quality & Regulatory Specialist

Crux Product Design; Bristol; On-site; GBP 40,000 - 60,000; Full time

Job summary

A leading medical device consultancy in Bristol is looking for an experienced Quality & Regulatory Specialist to enhance regulatory compliance and support global projects. You will work with top pharmaceutical clients and collaborate with a multidisciplinary team, contributing to healthcare innovation. Candidates should have experience in quality management and regulatory affairs, with a strong scientific background. This position offers travel opportunities and a dynamic work environment.

Benefits

Travel opportunities

Collaborative work environment

Influence in healthcare technology development

Qualifications

• Proven experience in a relevant Quality/Regulatory context relating to medical devices.
• Experience with established quality and regulatory guidelines.
• Strong degree in a relevant scientific discipline.

Responsibilities

• Enhance project-specific regulatory compliance.
• Lead quality and regulatory initiatives across various disciplines.
• Oversee validation of computer-based systems.

Skills

Regulatory compliance

Quality management

Cross-functional collaboration

Risk management

Usability engineering

Education

Strong degree in a relevant scientific/healthcare-related discipline

Tools

Quality Management System (QMS)

ISO 9001

ISO 13485

ISO 14971

Job description

Position Overview

Are you passionate about shaping the future of medical device quality? Join a team of expert design engineers and human factors specialists driving innovation for the world’s leading pharmaceutical and medical device companies.

At Crux, we believe that curiosity drives innovation. As a specialist consultancy at the forefront of medical device development, we deliver safe, user‑centred solutions that transform healthcare globally.

As part of recent growth and expansion, we’re recruiting an experienced and passionate Quality & Regulatory Specialist to join our growing team and lead impactful work across a diverse portfolio of global projects.

Based in our Bristol office, we are looking for a talented quality and regulatory professional that can combine technical expertise with a drive towards quality management and regulatory affairs, supporting project delivery from concept development and regulatory strategy through to pilot manufacturing into verification and validation studies.

Why Crux?

• Work with top pharma clients on cutting‑edge medical device projects.
• Collaborate with a multidisciplinary team across our Bristol (UK) and Boston (US) offices.
• Travel opportunities to support global project delivery.
• Influence the development of life‑changing healthcare technologies.
• Be part of a consultancy that values curiosity, integrity, and collaboration.

Principal Responsibilities

As a Quality and Regulatory Specialist, you’ll play a key role in enhancing project‑specific regulatory compliance and using experience and knowledge to enhance our ISO 9001, ISO 13485, and ISO 14001 certified Quality Management System (QMS). You’ll lead quality and regulatory initiatives across:

• Human Factors & Usability Engineering
• Device Design & Development
• Risk Management & ISO 14971 Compliance
• Computer System Validation
• Quality Agreements & Contracts
• Environmental & Sustainability Reporting

Core Responsibilities:

• Quality and regulatory support for the planning and execution of Usability studies in compliance with EU and US regulations.
• Quality and regulatory support for the planning and execution of Device Design & Development in compliance with EU and US regulations.
• Quality and regulatory support for the planning and execution of pre‑clinical and clinical research activities in compliance with EU and US regulations.
• Ensure device risk management aligns with ISO 14971 and current regulatory guidance.
• Oversee validation of computer‑based systems used in regulatory and QMS activities.
• Maintain and improve QMS processes, including documentation, audits, and change control.
• Build trusted client relationships and identify opportunities for process improvement.
• Manage quality agreements and support contract development.
• Support with environmental management and sustainability reporting.

What We’re Looking For

Essential

• Proven experience in a relevant Quality/Regulatory context relating to medical devices (and some familiarity with drug‑device combination products is desirable).
• Experience working to established quality and regulatory guidelines for activities relating to Human Factors, Usability, Design & Development and Risk Management.
• Strong cross‑functional collaboration skills and stakeholder engagement.
• Experience validating software systems within a QMS context.
• Skilled in medical device risk management and usability integration.
• Familiarity with quality agreements and contract implementation.
• Excellent communication, planning, and attention to detail.
• Willingness to travel to support global project delivery.
• Strong degree in a relevant scientific/healthcare‑related discipline.

Desirable

• Consultancy experience in medical, pharma, or health sectors.
• Strong academic background.
• Confident communicator and proactive problem‑solver.
• Passion for mentoring and knowledge sharing.
• Up-to-date with industry trends and best practices.
• Curious, collaborative, and committed to making a difference.