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 now searching for an experienced Compliance Engineer to join a exciting medical device organisation and support regulatory compliance across the full product lifecycle.

This Compliance Engineer opportunity would suit someone with strong technical documentation experience who enjoys working across Quality, Engineering, NPD and Manufacturing within a highly regulated environment.

The Role

As Compliance Engineer, you will be responsible for creating, reviewing and maintaining regulatory and technical documentation to ensure products remain compliant and audit-ready.

Key Compliance Engineer responsibilities will include:

• Authoring and maintaining Technical Files, Design Dossiers 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 activities.
• Reviewing documentation for accuracy, completeness and regulatory compliance.
• Managing documentation updates following design, process or regulatory changes.
• Supporting risk management and design control documentation.
• Assisting with Notified Body, Competent Authority and external audit requirements.
• Monitoring changes to regulations, standards and guidance.
• Supporting post-market compliance and regulatory change assessments.
• Contributing to continuous improvement of Quality and Regulatory processes.

About You

The successful Compliance Engineer will ideally have:

• Experience within medical devices, pharmaceuticals or another regulated life sciences environment.
• Strong 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 organisational and cross-functional communication skills.

The Compliance Engineer will work closely with Quality, Engineering, Product Development and Manufacturing teams, providing compliance input into both existing products and new product development.

This Compliance Engineer position offers the opportunity to take ownership of meaningful compliance activities while developing broader exposure across regulatory submissions, product lifecycle management and international medical device requirements.