Medical Device Regulatory Compliance Lead (MDR/ISO 13485)

Aurora Lifesciences; South Yorkshire; On-site; GBP 40,000 - 70,000; Full time

Job summary

Aurora Lifesciences is seeking an experienced Regulatory Compliance Specialist to join a 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 ensure products remain compliant, audit-ready, and aligned with EU MDR and UK requirements.

You will collaborate with Quality, Engineering, NPD and Manufacturing teams on ongoing regulatory submissions and

Qualifications

• Experience creating and maintaining controlled technical documentation.
• Knowledge of EU MDR 2017/745 and ISO 13485.
• Understanding of design control and risk management.
• Experience supporting regulatory submissions.

Responsibilities

• Authoring and maintaining Technical Files and regulatory documentation.
• Supporting EU MDR and UK regulatory compliance activities.
• Preparing regulatory reports and declarations.
• Supporting regulatory submissions and market access activities.
• Reviewing documentation for accuracy and regulatory compliance.
• Managing documentation updates after design or regulatory changes.

Skills

Medical devices

Technical writing

Regulatory submissions

ISO 13485

EU MDR

Cross-functional comms

Regulatory compliance

Job description

Aurora Lifesciences is seeking an experienced Regulatory Compliance Specialist to join a 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 ensure products remain compliant, audit-ready, and aligned with EU MDR and UK requirements.

You will collaborate with Quality, Engineering, NPD and Manufacturing teams on ongoing regulatory submissions and