Regulatory Strategy Engineer – Medical Devices

Newton Colmore Consulting; Cambridge; On-site; GBP 50,000 - 70,000; Full time

Job summary

Newton Colmore Consulting is seeking a Regulatory Affairs Engineer for Cambridge, to support medical devices across diverse projects. You will work at the intersection of design, innovation and compliance, partnering with design engineers, scientists and project teams to ground development in robust regulatory thinking.

You will apply ISO 9001, ISO 13485 and FDA 21 CFR 820 knowledge, develop regulatory strategies, interpret requirements, track changes and contribute to the quality management

Qualifications

• Regulatory thinking and guidance for medical devices.
• Interpreting requirements and implementing design controls.
• Knowledge of ISO 9001, ISO 13485 and FDA 21 CFR 820.
• Tracking regulatory changes and communicating implications.

Responsibilities

• Deliver hands-on regulatory support across multiple projects.
• Contribute to the operation and improvement of the quality system.
• Support internal and external audits and provide regulatory guidance.
• Align development activities with international regulatory requirements.

Job description

Newton Colmore Consulting is seeking a Regulatory Affairs Engineer for Cambridge, to support medical devices across diverse projects. You will work at the intersection of design, innovation and compliance, partnering with design engineers, scientists and project teams to ground development in robust regulatory thinking.

You will apply ISO 9001, ISO 13485 and FDA 21 CFR 820 knowledge, develop regulatory strategies, interpret requirements, track changes and contribute to the quality management