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.