Regional Regulatory Affairs Manager

Key Responsibilities

• Regulatory Strategy & Operations
• Lead regulatory activities across assigned countries for all medical device portfolios.
• Develop regulatory strategies to support new product launches, product lifecycle management and market expansion.
• Ensure timely submission of product registrations, renewals, amendments, notifications and regulatory maintenance activities.
• Monitor registration timelines and proactively manage risks affecting commercial launch plans.
• Maintain regulatory compliance with local medical device regulations and applicable standards.
• Lead, coach, and develop the Regional Regulatory Affairs team.
• Allocate resources, prioritise workloads, and set performance objectives across countries and business units.
• Foster a high-performing, collaborative, and customer-focused team culture.
• Monitor regulatory changes, assess business impact and risks, and l...