Advanced Quality & Regulatory Engineer, Medical Devices

Crux Product Design Ltd; Bristol; On-site; GBP 70,000 - 100,000; Full time

Benefits offered by this job

Holiday allowance

Life assurance

Pension scheme

Bike-to-work

Health cash plan

Enhanced family leave

Social events

Job summary

Crux Product Design Ltd is seeking an experienced Advanced Quality & Regulatory Engineer based in Bristol. You will lead regulatory strategy for medical devices and drug-device combinations, collaborate with engineers, scientists and designers, and drive submissions to global regulators.

You will influence product development decisions, manage risk, and ensure compliance with EU MDR and FDA guidance across diverse projects for leading healthcare organisations. Travel may be required.

Qualifications

• Proven experience in regulatory development for medical devices and drug-device combinations.
• Experience applying ISO 13485, IEC 62366-1, ISO 14971 and FDA guidance.
• Strong cross-functional collaboration and stakeholder engagement.
• Excellent communication, planning and attention to detail.

Responsibilities

• Develop regulatory strategy for medical devices and drug-device combos across global markets.
• Oversee design and development activities throughout the lifecycle.
• Manage risk processes (ISO 14971) and usability integration.
• Guide development in line with EU MDR and FDA guidance.
• Prepare and manage technical documentation for submissions (510K, PMA, etc).

Skills

Regulatory strategy

Cross-functional collaboration

Regulatory submissions

Quality management

Education

Degree in regulatory/science/engineering

Job description

Crux Product Design Ltd is seeking an experienced Advanced Quality & Regulatory Engineer based in Bristol. You will lead regulatory strategy for medical devices and drug-device combinations, collaborate with engineers, scientists and designers, and drive submissions to global regulators.

You will influence product development decisions, manage risk, and ensure compliance with EU MDR and FDA guidance across diverse projects for leading healthcare organisations. Travel may be required.