Global Regulatory Strategy Lead, IVD & CDx

Adaptive Biotechnologies Corp.; United States; On-site; USD 145,000 - 217,000; Full time

Benefits offered by this job

Equity grant

Bonus eligible

Job summary

Adaptive Biotechnologies Corp. is seeking a Senior Manager, Regulatory Affairs to lead ex-US regulatory strategy for our NGS-based IVD products, starting with EU IVDR and Health Canada, and expanding to other markets as we grow globally.

You will drive regulatory programs for biopharma co-development and companion diagnostics, coordinate with US FDA pathways, mentor the regulatory team, and help shape international clinical/regulatory pathways for future trials and submissions.

Qualifications

• Bachelor’s degree in life sciences or related field; advanced degree preferred.
• 12+ years in regulatory affairs for IVD/biotech; EU IVDR and Health Canada experience.
• 2+ years of supervisory experience.
• Experience engaging with regulatory authorities and Notified Bodies.
• Strong written and verbal communication; leadership of teams.

Responsibilities

• Lead ex-US regulatory strategy (EU IVDR, Health Canada) and future markets.
• Manage regulatory roadmap and liaison with authorities.
• Lead CDx and biopharma co-development regulatory activities.
• Support US FDA pathways and cross-functional alignment.
• Mentor regulatory staff and contribute to budgeting.

Skills

Regulatory affairs

Leadership

Communication skills

FDA knowledge

Cross-functional collaboration

Education

Bachelor’s degree

Advanced degree preferred

Job description

Adaptive Biotechnologies Corp. is seeking a Senior Manager, Regulatory Affairs to lead ex-US regulatory strategy for our NGS-based IVD products, starting with EU IVDR and Health Canada, and expanding to other markets as we grow globally.

You will drive regulatory programs for biopharma co-development and companion diagnostics, coordinate with US FDA pathways, mentor the regulatory team, and help shape international clinical/regulatory pathways for future trials and submissions.