Job Description

Develop, review, and maintain regulatory documentation in accordance with EU MDR 2017/745, including technical documentation, risk management files, and clinical evaluation reports. Conduct gap assessments against EU MDR requirements to identify areas for improvement and support implementation strategies. Coordinate with cross-functional teams to gather data and ensure alignment of regulatory submissions with product design and development processes. Stay updated on relevant regulatory testing requirements and ensure compliance with applicable standards. Support the preparation of Notified Body submissions, responses to queries, and audit readiness. Assist in the compilation and submission of US FDA 510(k) dossiers, including predicate device analysis and regulatory strategy. Interpret global regulatory requirements and translate them into clear guidance and actionable plans for internal and client teams. Qualifications & Skills: Bachelors or Masters degree in life sciences, biomedical engineering, pharmacy, or a related field. Minimum 1-2 years of hands-on experience in regulatory affairs within the medical device industry. Demonstrated expertise in EU MDR 2017/745, with experience preparing clinical, risk, and performance documentation. Strong understanding of ISO 14971 and MEDDEV guidance. Familiarity with FDA 21 CFR Part 820 and 510(k) submission process is a plus. Excellent communication, documentation, and project management skills. Ability to work independently, prioritise tasks, and manage deadlines across multiple projects.