Regulatory Specialist

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

Job summary

Aurora Lifesciences seeks an experienced Regulatory Specialist to join a medical device organisation and manage regulatory documentation throughout the product lifecycle.

You will author, review and maintain Technical Files and regulatory records, support EU MDR and UK compliance, and drive regulatory submissions and post-market activities across Quality, Engineering, NPD and Manufacturing.

Qualifications

• Experience in medical devices or regulated life sciences.
• 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.

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

Regulatory compliance

Technical writing

Documentation control

Cross-functional collaboration

EU MDR

ISO 13485

Job description

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

This Regulatory 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 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 Specialist 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 Regulatory 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 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.