Regulatory Affairs Project Manager

JOB DESCRIPTION

Job Title

Regulatory Affairs Project Manager

Job Description

Regulatory Affairs Project ManagerYour role:•Lead and drive global regulatory strategy and execution for new product introductions and lifecycle management activities within the Ambulatory Monitoring & Diagnostics business.
• Act as the regulatory lead on cross‑functional project teams, ensuring alignment between product development activities and applicable regulatory requirements.
• Manage and drive regulatory projects in close partnership with program management, R&D, Clinical, and commercial teams to enable timely market access.
• Serve as the primary point of contact for regulatory project execution and project-related regulatory support.
• Assess regulatory impacts of product changes and support change management activities, including global registration updates.
• Identify regulatory risks and proactively develop mitigation strateg...