Regulatory Affairs Project Manager

About the role

Lead and drive global regulatory strategy and execution for new product introductions and lifecycle management within the Ambulatory Monitoring & Diagnostics business. Serve as the regulatory lead on cross‑functional project teams, ensuring alignment between product development and regulatory requirements.

Key responsibilities

• Develop and implement global regulatory strategies for product launches and lifecycle updates.
• Act as the primary regulatory point of contact on cross‑functional projects, coordinating with program management, R&D, Clinical, and commercial teams.
• Assess regulatory impacts of product changes and manage global registration updates.
• Identify regulatory risks and create mitigation plans to support approvals.
• Monitor evolving global regulatory requirements and provide strategic guidance.
• Lead projects related to new or changing regulations, internal process improvements, and administrative support.
• Maintain clear communication of project status, risks, dependencies, and timelines to teams and leadership.

Required profile

• Bachelor’s or Master’s degree in Life Sciences, Engineering, Regulatory Affairs or a related field.
• 5+ years of experience in Regulatory Affairs and/or project management within medical devices, digital health or the healthcare industry.
• Strong knowledge of global regulatory frameworks such as FDA 21 CFR, EU MDR/IVDR and other international requirements.
• Proven ability to define, execute and deliver regulatory strategies and projects.
• Excellent ability to manage multiple priorities and influence cross‑functional, matrixed teams.
• Strong communication and stakeholder management skills.
• Solid project and resource management capabilities.

Required skills