Global Regulatory Affairs Leader, Diagnostics Solutions

LumiraDx Limited; Boston (MA); On-site; USD 347,000 - 455,000; Full time

Benefits offered by this job

Relocation benefits

Annual bonus

Job summary

Roche seeks a Global Head of Regulatory Affairs to lead a high‑performing team delivering global regulatory registrations for Diagnostic solutions. You will partner with senior leaders, drive strategy across regions, and ensure timely, compliant submissions to enable patient access worldwide.

You will oversee resource management, build capabilities, and promote agile practices while maintaining Roche values and industry leadership in diagnostics.

Qualifications

• 15+ years of progressively responsible Regulatory management experience in International and US.
• Experience in Dia or MedTech or both.
• Regulatory arena and IVD field experience.
• 5-7 years leading and managing teams and budgets.
• Proven filings experience (510k, PMA, IDEs) and FDA/global regulator negotiations.
• University degree in a relevant field; post-graduate degree preferred.
• Strong leadership with global/diverse teams and matrix leadership.

Responsibilities

• Provide strategic direction for Global Regulatory Submissions with cross-regional leadership.
• Serve as regulatory liaison with US FDA, international agencies, and affiliates.
• Ensure timely availability of registration data and dossiers for global access.
• Monitor regulatory environments and assess impact of changes.
• Drive standardised regulatory processes and submission strategies.
• Lead and grow the Regulatory Affairs team and manage resources.
• Foster agile ways of working and high-quality submissions.
• Inspire leaders and deliver innovative Diagnostics solutions.

Skills

Regulatory leadership

FDA negotiations

Global registrations

Matrix leadership

Strategic thinking

People development

Stakeholder management

Change leadership

Education

University degree

Post-graduate qualification (MSc/MBA) preferred

Tools

QMS systems

Job description

Roche seeks a Global Head of Regulatory Affairs to lead a high‑performing team delivering global regulatory registrations for Diagnostic solutions. You will partner with senior leaders, drive strategy across regions, and ensure timely, compliant submissions to enable patient access worldwide.

You will oversee resource management, build capabilities, and promote agile practices while maintaining Roche values and industry leadership in diagnostics.