Compliance & Regulatory Engineer

Purpose of the Role

The Compliance & Regulatory Engineer will support regulatory compliance activities across a regulated medical device organisation, ensuring that technical and regulatory documentation remains accurate, complete and audit-ready throughout the product lifecycle.

The role will have a strong focus on the creation, authoring, review and maintenance of technical documentation, compliance records and regulatory submissions.

Working cross-functionally with Regulatory Affairs, Quality Assurance, Engineering, New Product Development and Manufacturing teams, the successful candidate will help ensure products and associated processes continue to meet applicable regulatory, quality and compliance requirements.

The position reports into a senior technical and compliance leader within the organisation.

Key Responsibilities

• Author, maintain and update Technical Files, Design Dossiers and supporting regulatory documentation.
• Create and maintain compliance records, technical reports, declarations and other regulatory deliverables.
• Support the preparation and maintenance of risk management documentation.
• Compile documentation required for regulatory submissions, registrations and market access activities.
• Review technical documentation for completeness, consistency, accuracy and compliance with applicable regulatory and quality requirements.
• Coordinate documentation updates resulting from design changes, manufacturing changes, process improvements or changes to regulatory requirements.
• Assist with product classifications, regulatory product schedules and applicable coding requirements, including GMDN classifications where appropriate.
• Support new product development activities by ensuring design and development documentation meets applicable regulatory and compliance requirements.
• Work closely with Engineering, Quality and project teams to ensure regulatory requirements are incorporated throughout product development and change activities.
• Support internal, external and regulatory audits by preparing documentation and providing appropriate supporting evidence.
• Assist with interactions and submissions involving Notified Bodies, Competent Authorities and other international regulatory organisations.
• Monitor changes to relevant regulations, standards and guidance and assess their potential impact on products and business processes.
• Communicate relevant regulatory changes and requirements to internal stakeholders.
• Contribute to the development and continuous improvement of regulatory and Quality Management System procedures.
• Support post-market compliance activities, including documentation reviews and regulatory change assessments.
• Maintain current knowledge of medical device regulations, standards and compliance requirements relevant to the organisation’s products and markets.

Qualifications

• Degree in Engineering, Biomedical Engineering, Life Sciences or another relevant scientific or technical discipline.
• Additional training or professional certification in Regulatory Affairs, Medical Devices or Quality Management Systems would be advantageous.

Experience

The successful candidate should ideally have:

• Experience working within a regulated medical device, pharmaceutical or wider life sciences environment.
• Experience creating, reviewing and maintaining controlled technical documentation.
• Experience working within an ISO 13485 Quality Management System or a comparable regulated quality environment.
• Experience supporting regulatory compliance activities throughout the product lifecycle.
• Exposure to regulatory submissions, technical file preparation or product registrations would be advantageous.
• Experience working cross-functionally with Quality, Engineering, Manufacturing or Product Development teams.

Knowledge

• Good understanding of medical device regulatory and compliance principles.
• Familiarity with EU Medical Device Regulation (EU MDR 2017/745).
• Awareness of UK medical device regulatory requirements.
• Understanding of ISO 13485 Quality Management Systems.
• Knowledge of design controls, risk management and technical documentation requirements.
• Awareness of international medical device regulatory requirements would be beneficial.

Skills & Behaviours

• Strong technical writing and document-authoring capability.
• Excellent attention to detail and the ability to critically review technical information for accuracy and compliance.
• Methodical and organised approach to managing multiple priorities, projects and deadlines.
• Strong analytical and problem-solving skills.
• Effective communication skills with the ability to work across multidisciplinary teams.
• Confident working independently and taking ownership of regulatory and compliance activities.
• Comfortable managing documentation, records and compliance information within electronic Quality Management Systems.
• Able to use initiative and contribute effectively to cross-functional projects and continuous improvement initiatives.