Quality and Regulatory Engineer

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

Benefits offered by this job

Travel opportunities for global projects

Collaboration with multidisciplinary teams

Impactful work on healthcare technologies

Job summary

A consultancy in medical device development in Bristol is seeking a Quality & Regulatory Engineer passionate about ensuring device development aligns with latest guidelines. The role involves maintaining the ISO-certified QMS, supporting audits, and contributing to risk management. Ideal candidates will possess a good degree in a relevant discipline, extensive experience in quality assurance, and strong analytical skills. This position offers the opportunity to work with top pharmaceutical clients and influence the development of life-changing healthcare technologies.

Qualifications

• Strong relevant sector experience in Medical Device Quality Assurance and Regulatory Compliance.
• Awareness of medical device related standards and guidelines (IEC 62366-1, ISO 14971, EU MDR, FDA guidance).
• Experience in technical documentation and regulatory submissions is desirable.

Responsibilities

• 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.

Skills

Medical Device Quality Assurance

Regulatory Compliance

Analytical Skills

Problem-Solving Skills

Attention to Detail

Effective Communication

Education

Good degree in a relevant scientific/healthcare discipline

Job description

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.

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