Regulatory Compliance Specialist

Aurora Lifesciences; South Yorkshire; Sur place; GBP 40 000 - 70 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Medical devices

Technical writing

Regulatory submissions

ISO 13485

EU MDR

Cross-functional comms

Regulatory compliance

Description du poste

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

This Regulatory Compliance Specialist 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 a Regulatory Compliance Specialist, 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 Regulatory Compliance Specialist will ideally have:

• Experience within medical devices (Essential)
• 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 Regulatory Compliance Specialist will work closely with Quality, Engineering, Product Development and Manufacturing teams, providing compliance input into both existing products and new product development.

This Regulatory Compliance Specialist 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.