Quality and Regulatory Engineer

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

Job summary

A leading consultancy in medical device development is seeking a Quality & Regulatory Engineer in Bristol. This role involves ensuring compliance with medical device standards, supporting the QMS, and contributing to impactful global projects. The ideal candidate has a relevant degree and strong experience in quality assurance and regulatory compliance. Opportunities for mentorship and collaboration are integral to the role, fostering a culture of curiosity and integrity.

Qualifications

• Experience in Medical Device Quality Assurance and Regulatory Compliance.
• Knowledge of IEC 62366-1, ISO 14971, EU MDR, and FDA guidance.

Responsibilities

• Embed quality throughout product development.
• Support validation of QMS systems.
• Contribute to risk management activities.
• Develop training materials for quality awareness.

Skills

Medical Device Quality Assurance

Regulatory Compliance

Analytical skills

Problem-solving

Attention to detail

Communication

Education

Relevant scientific/healthcare-related degree (Masters preferred)

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.

We’re hiring in our Bristol office for a role that blends quality management and regulatory awareness to ensure that device development activities align with the latest guidelines.

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. We’re looking for an experienced and passionate Quality & Regulatory Engineer to join our growing team and support impactful work across a diverse portfolio of global projects.

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 & Regulatory Engineer, you’ll help maintain and improve our ISO‑certified QMS across human factors, device development, risk management, system validation, and sustainability. You will:

• Embed quality throughout product development.
• Support validation of QMS systems.
• Support audits and change control.
• Contribute to risk management activities.
• Develop training materials to strengthen quality awareness.

What We’re Looking For

Essential

• A good degree in a relevant scientific/healthcare‑related discipline (preferably Masters level).
• Strong relevant sector experience in Medical Device Quality Assurance and Regulatory Compliance.
• Awareness of medical device related standards, regulations and guidelines (IEC 62366-1, ISO 14971, EU MDR, and FDA guidance)
• Strong analytical and problem‑solving skills.
• Excellent attention to detail and organisational skills.
• Effective communication skills and the ability to work within a collaborative team environment.

Desirable

• Experience in technical documentation and regulatory submissions.
• 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.