[Hiring] Senior Manager, Regulatory Affairs @Adaptive Biotechnologies

Role Description

The Senior Manager, Regulatory Affairs leads the development and execution of ex-US regulatory strategy for the company's NGS-based in vitro diagnostic (IVD) products, focusing initially on the EU In Vitro Diagnostic Regulation (IVDR) and Health Canada. This role also owns the regulatory relationship with biopharma partners for companion diagnostic (CDx) and complementary diagnostic co-development programs.

• Own and evolve the company's ex-US regulatory strategy.
• Build the regulatory roadmap for future international expansion.
• Serve as primary point of contact and lead negotiator with international regulatory authorities and Notified Bodies.
• Monitor global regulatory intelligence and translate changes into actionable strategy.
• Own and maintain international technical files and post-market surveillance obligations.
• Serve as the regulatory lead for biopharma co-development and companion diagnostic partnerships.
• Maintain working knowledge of US FDA pathways relevant to NGS IVDs.
• Mentor and provide technical/strategic guidance to junior Regulatory team members.
• Partner closely with R&D, Quality, and other teams to ensure regulatory considerations are embedded early in product development.
• Contribute to departmental budgeting, resourcing, and process/SOP development for international regulatory operations.

Qualifications

• Bachelor's degree in a life sciences, engineering, or related scientific discipline; advanced degree (MS, PhD, or equivalent) preferred.
• 12+ years of progressive regulatory affairs experience in IVD, molecular diagnostics, medical device, or biopharmaceutical industries.
• 2+ years of supervisory experience.
• Demonstrated experience developing and executing global/international regulatory strategy.
• Working knowledge of US FDA regulatory frameworks for IVDs.
• Experience interfacing directly with regulatory authorities and/or Notified Bodies.
• Strong knowledge of quality system frameworks relevant to IVDs.
• Excellent written and verbal communication skills.
• Proven people leadership or matrixed team leadership experience.

Requirements

• Direct experience supporting biopharma companion diagnostic co-development programs.
• Clinical trial, clinical affairs, or clinical research regulatory experience.
• Experience with additional international markets beyond IVDR/Health Canada.
• Familiarity with data privacy/genomic data considerations relevant to international markets.

Benefits

• Salary Range: $144,600 - $217,000
• Equity grant
• Bonus eligible