Advanced Quality & Regulatory Engineer

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

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).

• 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…