Global Regulatory Affairs Lead – IVD & CDx (EU/Canada)

Adaptive Biotechnologies; United States; Remote; USD 145,000 - 217,000; Full time

Job summary

Adaptive Biotechnologies is seeking a Senior Manager, Regulatory Affairs to lead ex-US regulatory strategy for NGS-based IVD products, starting with EU IVDR and Health Canada, and expanding to UKCA, TGA, NMPA, and other markets. This role also owns regulatory partnerships with biopharma for CDx programs and coordinates with US FDA pathways to align international clinical and regulatory plans.

Leaders here drive collaboration across R&D, Quality, and clinical teams.

Qualifications

• Bachelor’s degree in a life sciences, engineering, or related field.
• 12+ years of progressive regulatory affairs experience in IVD/diagnostics.
• 2+ years of supervisory experience.
• Experience with EU IVDR, Health Canada licensing, and US FDA pathways.
• Strong leadership and cross-functional collaboration skills.

Responsibilities

• Lead ex-US regulatory strategy and international roadmap.
• Engage with Notified Bodies and regulatory authorities.
• Mentor regulatory staff and coordinate with R&D, Quality, and clinical teams.
• Drive regulatory submissions and labeling inputs for CDx programs.

Skills

Regulatory strategy

Leadership

Stakeholder management

US FDA knowledge

EU IVDR knowledge

Education

Bachelor’s degree in life sciences / engineering

MS/PhD preferred

Tools

Notified Bodies coordination

Quality systems knowledge (ISO 13485)

Clinical trial coordination

Job description

Adaptive Biotechnologies is seeking a Senior Manager, Regulatory Affairs to lead ex-US regulatory strategy for NGS-based IVD products, starting with EU IVDR and Health Canada, and expanding to UKCA, TGA, NMPA, and other markets. This role also owns regulatory partnerships with biopharma for CDx programs and coordinates with US FDA pathways to align international clinical and regulatory plans.

Leaders here drive collaboration across R&D, Quality, and clinical teams.