Medical Device Compliance Engineer — Regulatory Submissions

Aurora Life Sciences; Doncaster; On-site; GBP 42,000 - 64,000; Full time

Job summary

Aurora Life Sciences is seeking an experienced Compliance Engineer to join our medical device team and ensure regulatory compliance across the full product lifecycle. You will create, review and maintain technical documentation, support EU MDR, UK regulations, and post-market activities while collaborating with Quality, Engineering and Manufacturing.

The role offers exposure to regulatory submissions, Notified Bodies and continual process improvement.

Qualifications

• Experience in medical devices and regulated life sciences environments.
• Strong ability to create and maintain controlled technical documentation.
• Knowledge of EU MDR 2017/745, ISO 13485, ISO14971.
• Experience supporting regulatory submissions or Technical File activities.
• Excellent technical writing and attention to detail.
• Strong organizational and cross-functional communication skills.

Responsibilities

• 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.

Skills

Regulated life sciences

ISO13485

EU MDR 2017/745

Technical documentation

Regulatory submissions

Risk management

Design control

Technical writing

Cross-functional comms

Job description

Aurora Life Sciences is seeking an experienced Compliance Engineer to join our medical device team and ensure regulatory compliance across the full product lifecycle. You will create, review and maintain technical documentation, support EU MDR, UK regulations, and post-market activities while collaborating with Quality, Engineering and Manufacturing.

The role offers exposure to regulatory submissions, Notified Bodies and continual process improvement.