Regulatory Affairs Lead Specialist

Regulatory Affairs Lead Specialist (Fixed-Term Contract – Maternity Cover)

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