Regional Regulatory Affairs Specialist

About the role

The role supports the Regional Regulatory function, providing regulatory affairs expertise for commercial operations across the region.

Key responsibilities

• Prepare and submit regulatory dossiers for new product launches, line extensions, and renewals.
• Engage with health authorities to secure product clearances and maintain regulatory compliance.
• Provide regulatory documentation to support commercial tenders and contracts.
• Evaluate product, labeling, and manufacturing changes and submit change notifications.
• Act as internal SME, advising cross‑functional teams and senior leadership on regulatory trends.
• Collaborate on adverse event reporting, recall management, and audit activities.
• Continuously improve internal regulatory processes and regional governance.

Required profile

• Minimum 3 years of regulatory experience, preferably in the med‑tech industry.
• Project management experience with ability to handle multiple priorities.
• Familiarity with regulatory policy frameworks and global trends.
• Strong analytical skills to interpret complex regulatory information.
• Excellent communication skills, both written and verbal.

Required skills

• Regulatory affairs expertise in medical devices.
• Project management capabilities.
• Analytical assessment of regulatory impact.
• Effective cross‑functional collaboration.