Regulatory Affairs, Clinical Executive

The Regulatory Affairs Executive will support clinical development programs by preparing and maintaining regulatory documentation for medical devices, equipment, and supplies used in clinical trials. The role involves coordinating dossier preparation, ensuring compliance with regional and international regulatory requirements, and assisting in submissions to relevant authorities. The executive will collaborate closely with project management, clinical, and supply chain teams to ensure regulatory alignment across study timelines and sites. Day-to-day responsibilities include monitoring regulatory changes, supporting audits and inspections, maintaining accurate records, and contributing to continuous improvement of regulatory processes and templates.
Qualifications
Strong foundation in regulatory affairs, including Regulatory Affairs and Regulatory Requirements relevant to clinical trials.
Experience with Regulatory Documentation and Dossier Preparation for medical devices, equipment, and clinical trial supplies.
Demonstrated understanding of Regulatory Compliance in a healthcare, biopharmaceutical, or clinical research setting.
Knowledge of clinical trial processes, ICH-GCP guidelines, and regional regulatory frameworks.
Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biomedical Engineering, or a related field.
Excellent written and verbal communication skills, with attention to detail and accuracy in documentation.
Ability to work collaboratively with cross-functional teams and manage multiple projects and deadlines.
Proficiency with standard office software and document management tools; experience with quality management systems is an advantage.
Prior experience in regulatory affairs or clinical operations, preferably within medical devices or biopharmaceuticals, is highly beneficial.

Work arrangement
No