Advanced Quality & Regulatory Engineer — Global MedTech Impact

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

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.