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Regulatory Affairs Lead Specialist (Fixed-Term Contract – Maternity Cover) About the Opportunity A global MedTech organization developing innovative medical devices is looking for a Regulatory Affairs Lead Specialist to support international regulatory activities during a maternity cover period. This role will play a key part in driving regulatory strategy and submissions across global markets, working closely with cross-functional teams to ensure compliance and timely product approvals. Key Responsibilities Lead global regulatory projects to secure market authorization and promotional approvals for medical devices Develop and implement regulatory strategies aligned with business objectives, including target markets, clinical claims, and timelines Define testing and clinical study requirements to support regulatory submissions Prepare and submit regulatory dossiers across global markets (US, Europe, Canada, LATAM, Asia, China) Provide regulatory guidance throughout the product development lifecycle Assess design changes and determine regulatory impact and submission requirements Review and approve promotional materials to ensure compliance with regulatory claims Monitor regulatory trends and updates, ensuring internal alignment Support audits and inspections as required Profile Strong experience in Regulatory Affairs within the medical device industry Solid understanding of global regulatory frameworks and submission processes Strong analytical, problem-solving, and project management skills Excellent communication skills, both written and verbal Fluency in English Preferred Experience Experience interacting with global regulatory authorities (e.g. FDA, Notified Bodies, NMPA) Knowledge of Quality Management Systems (QMS) and regulatory compliance frameworks Ability to work independently in a dynamic, fast-paced environment