Advanced Quality & Regulatory Engineer

Crux Product Design Ltd; West of England; On-site; GBP 65,000 - 90,000; Full time

Job summary

Crux Product Design Ltd in Bristol looks for an Advanced Quality & Regulatory Engineer to guide regulatory strategy and device development across global markets. You will collaborate with the Head of Quality, Regulatory, Risk and Assurance to drive compliant design and documentation for market approvals.

The role emphasizes ISO standards, cross-functional leadership, and opportunities to mentor within a growing consultancy team. Travel to support global projects is expected.

Qualifications

• Degree or equivalent experience in a relevant scientific, engineering, healthcare or regulatory discipline.
• Proven experience in medical device and/or drug-device combination product development in a quality, regulatory or product development role.
• Experience applying design control principles throughout the medical device development lifecycle.
• Proven experience applying quality principles to device development, usability, and risk management.
• Experience authoring, reviewing or contributing to regulatory submissions and technical documentation.
• Willingness to travel to support global project delivery.

Responsibilities

• Regulatory strategy development for medical devices and drug-device combination products across global markets.
• Device design and development process management: overseeing and managing design and development activities throughout the development lifecycle.
• Risk management process (ISO 14971) management.
• Guiding development in line with applicable regulations such as EU MDR and FDA guidance.
• Preparing and managing technical documentation to support submissions.
• Regulatory communications and submissions, including preparation of technical documentation in support of market approval submissions (510K, PMA etc).

Skills

Regulatory strategy

Design control

Risk management

Quality principles

510K submissions

Cross-functional collaboration

Regulatory submissions

Communication

Travel willingness

Education

Degree in science/engineering

Job description

Position Overview

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

Position Overview

Are you passionate about shaping the future of medical device quality? Join a team of expert engineers and human factors specialists driving innovation for the world's leading pharmaceutical and 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 Advanced Quality & Regulatory Engineer 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 who is ready to take the next step in their career, combining technical expertise and regulatory knowledge to support progression of novel devices and technologies from design through to market.

This is an opportunity to work at the intersection of innovation, engineering and regulation, applying your expertise to novel medical devices and drug-device combination products for some of the world's leading healthcare organisations. You will have the opportunity to influence product strategy, guide development decisions and support regulatory success across a broad and diverse portfolio of projects.

No two projects are the same. You will work across a broad range of medical devices, combination products and emerging healthcare technologies, applying your expertise to diverse technical and regulatory challenges.

Working alongside engineers, scientists, human factors specialists, software developers and industrial designers, you will help shape products from concept through to market. You'll also have the opportunity to develop technical leadership, client-facing consultancy skills and mentoring responsibilities within a growing Quality, Regulatory, Risk & Assurance team.

Why Crux?

• Work across a diverse portfolio of novel medical devices and drug-device combination products, supporting global clients from early-stage innovation through to market approval.
• 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 an Advanced Quality & Regulatory Engineer, you'll play a key role in enhancing medical device development through strategic regulatory insights, device development experience, cross-functional collaboration and leadership.

In this role you will work closely with the Head of Quality, Regulatory, Risk and Assurance (QRRA) with responsibility for:

• Regulatory strategy development for medical devices and drug-device combination products across global markets.
• Device design and development process management: overseeing and managing design and development activities throughout the development lifecycle.
• Risk management process (ISO 14971) management.
• Guiding development in line with applicable regulations such as EU MDR (at the interface with medicinal product regulations) and FDA guidance.
• Preparing and managing technical documentation to support submissions.
• Regulatory communications and submissions, including preparation of technical documentation in support of market approval submissions (510K, PMA etc).

Essential

What We’re Looking For

• Degree or equivalent experience in a relevant scientific, engineering, healthcare or regulatory discipline.
• Proven experience within medical device and/or drug-device combination product development in a quality, regulatory or product development role.
• Experience applying design control principles throughout the medical device development lifecycle.
• Proven experience applying quality principles to device development, usability, and risk management in line with ISO 13485, IEC 62366-1, ISO 14971, and FDA guidance.
• Experience in 510K/PMA submissions and technical documentation creation and review.
• Strong cross-functional collaboration skills and stakeholder engagement.
• Skilled in medical device risk management and usability integration.
• Experience authoring, reviewing or contributing to regulatory submissions and technical documentation.
• Excellent communication, planning, and attention to detail.
• Willingness to travel to support global project delivery.

Desirable

• Experience working within a consultancy, client-services or contract development environment.
• 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.

Why you'll love working here

We're a dynamic, fast-growing engineering consultancy with a reputation for delivering brilliant work and for being a genuinely great place to build your career.

Our benefits package is designed to support your wellbeing and work-life balance. You'll enjoy a generous holiday allowance, life assurance, a generous pension scheme, bike-to-work options, a health cash plan, enhanced family leave and opportunities to get involved in social events throughout the year.

Check out what an opportunity at Crux offers you: Life at Crux

We are committed to building a diverse and inclusive workplace where everyone feels valued and supported. We welcome applications from people of all backgrounds, including those with disabilities, and strive to create an environment where different perspectives and experiences help us grow.

We're a Disability Confident employer. If you would like to make an application under the Disability Confident Scheme or need adjustments at any stage of the application and interview process (or once you join us!), just let us know and we'll make sure you have the support you need.