Medical Device Regulatory Compliance Engineer

Aurora Lifesciences; South Yorkshire; On-site; GBP 45,000 - 65,000; Full time

Job summary

Aurora Lifesciences is seeking an experienced Compliance Engineer to join a dynamic medical device organisation and support regulatory compliance across the full product lifecycle.

The role focuses on creating, reviewing and maintaining regulatory and technical documentation to keep products audit-ready, while partnering with Quality, Engineering, NPD and Manufacturing in a highly regulated environment.

Qualifications

• Experience with medical devices or regulated life sciences.
• Experience creating and maintaining controlled technical documentation.
• Knowledge of EU MDR 2017/745 and ISO 13485.
• Understanding of design control, risk management and technical documentation requirements.
• Experience supporting regulatory submissions or Technical File activities.
• Excellent technical writing and attention to detail.
• Strong cross-functional communication skills.

Responsibilities

• Authoring and maintaining Technical Files and regulatory documentation.
• Supporting EU MDR and UK regulatory compliance activities.
• Preparing technical reports, declarations and compliance records.
• Supporting regulatory submissions, registrations and market access.
• Reviewing documentation for accuracy and regulatory compliance.
• Managing documentation updates after design or regulatory changes.
• Supporting risk management and design control documentation.
• Assisting with Notified Body, Competent Authority and external audits.
• Monitoring changes to regulations, standards and guidance.
• Contributing to continuous improvement of Quality and Regulatory processes.
• Providing compliance input with Quality, Engineering, Product Development and Manufacturing teams.

Skills

Regulatory submissions

Technical writing

Cross-functional communication

Quality documentation

Job description

Aurora Lifesciences is seeking an experienced Compliance Engineer to join a dynamic medical device organisation and support regulatory compliance across the full product lifecycle.

The role focuses on creating, reviewing and maintaining regulatory and technical documentation to keep products audit-ready, while partnering with Quality, Engineering, NPD and Manufacturing in a highly regulated environment.