Medical Device Compliance Engineer

Aurora Lifesciences; South Yorkshire; On-site; GBP 50,000 - 70,000; Full time

Job summary

Aurora Lifesciences in the United Kingdom seeks a Compliance & Regulatory Engineer to drive regulatory and quality processes across the product lifecycle. The role focuses on creating, reviewing and maintaining technical documentation, compliance records and regulatory submissions, while collaborating with Regulatory Affairs, QA, Engineering and Manufacturing teams.

You will help ensure EU/UK MDR compliance, maintain risk management documentation, support audits and interact with authorities.

Qualifications

• Bachelor's or higher in engineering or life sciences or related technical field.
• Experience with regulatory affairs, medical devices, or QMS is advantageous.
• Familiarity with EU MDR/UK MDR and risk management practices.

Responsibilities

• Author, maintain and update technical files and regulatory documentation.
• Prepare regulatory submissions and market access documentation.
• Support risk management documentation and product classifications as needed.
• Review documentation for regulatory and quality compliance.
• Coordinate updates from design changes and regulatory requirements.
• Assist with audits and interactions with Notified Bodies and authorities.
• Monitor regulatory changes and communicate impact to teams.
• Contribute to QMS procedures and post-market compliance activities.

Skills

Regulatory writing

Document control

Quality systems

Cross-functional collaboration

Education

Degree in Engineering/Biomedical/Life Sciences

Job description

Aurora Lifesciences in the United Kingdom seeks a Compliance & Regulatory Engineer to drive regulatory and quality processes across the product lifecycle. The role focuses on creating, reviewing and maintaining technical documentation, compliance records and regulatory submissions, while collaborating with Regulatory Affairs, QA, Engineering and Manufacturing teams.

You will help ensure EU/UK MDR compliance, maintain risk management documentation, support audits and interact with authorities.