Senior Manager, Regulatory Affairs

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Position Overview

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, with a starting focus on the EU In Vitro Diagnostic Regulation (IVDR) and Health Canada, expanding over time to additional priority markets (e.g., UK/UKCA, Australia/TGA, China/NMPA, and other geographies as the international footprint grows). This role also owns the regulatory relationship with biopharma partners for companion diagnostic (CDx) and complementary diagnostic co-development programs, and maintains working knowledge of the US regulatory framework (FDA) to ensure a cohesive, globally aligned regulatory strategy. This individual will be a key strategic partner to the VP, Regulatory & Quality as the company builds out its clinical program, and will help shape international clinical and regulatory pathways for future NGS-based clinical trials and CDx submissions.

Leaders at Adaptive demonstrate behaviors consistent with Adaptive’s Core Values and Leadership Principles. Critical functions of your role include helping establish individual team member goals, aligning those individual goals with broader team objectives, and ensuring those objectives drive the achievement of company goals. Providing thoughtful coaching and consistent feedback to your team members will drive performance excellence and accountability, as well as support your team members’ growth and development. Leaders at Adaptive create an environment of belonging, respect, and open and honest communication every day.

Key Responsibilities and Essential Functions

International Regulatory Strategy

Own and evolve the company's ex-US regulatory strategy, prioritizing EU IVDR (technical documentation, Notified Body engagement, serve as PRRC, EU Declaration of Conformity) and Health Canada (Medical Device License applications, License amendments, Class III/IV IVD requirements) as the initial core markets.

Build the regulatory roadmap for future international expansion (e.g., UKCA, TGA, NMPA, other APAC/LATAM markets), including market-entry sequencing, gap assessments, and localization requirements.

Serve as primary point of contact and lead negotiator with international regulatory authorities and Notified Bodies; plan and lead regulatory agency/Notified Body meetings with support of the internal Regulatory leadership.

Monitor global regulatory intelligence (IVDR amendments, Health Canada guidance, IMDRF harmonization efforts, etc.) and translate changes into actionable strategy and internal process updates.

Own and maintain international technical files, design dossiers, and post-market surveillance/vigilance reporting obligations in coordination with Quality.

Biopharma & Companion Diagnostics

Serve as the regulatory lead for biopharma co-development and companion diagnostic partnerships, aligning CDx regulatory strategy with partner drug development timelines (US and international).

Represent the company in regulatory discussions with biopharma partners and, where applicable, joint health authority interactions related to CDx submissions.

Provide regulatory input into companion/complementary diagnostic labeling, indications for use, and co-development agreements.

Support integration of CDx regulatory requirements into NGS assay development and clinical validation planning.

US Regulatory Foundation & Cross-Functional Alignment

Maintain working knowledge of US FDA pathways relevant to NGS IVDs (510(k), De Novo, PMA, and CLIA/LDT considerations) to ensure international strategy remains harmonized with the US regulatory approach.

Partner with the Regulatory team to align global submission content, labeling, and change control assessments across regions.

Support the internal Regulatory leadership in building out the company's clinical program — providing regulatory input on international clinical trial requirements (e.g., EU/Health Canada clinical performance study requirements, ethics committee coordination) for NGS assays and CDx studies.

Leadership & Cross-Functional Collaboration

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 and lifecycle management.

Represent Regulatory on cross-functional product development and lifecycle teams; communicate risk assessments and mitigation plans to leadership.

Contribute to departmental budgeting, resourcing, and process/SOP development for international regulatory operations.

All other duties as assigned

Position Requirements (Education, Experience, Other)

Required 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, including direct, hands-on experience with EU IVDR technical documentation and Notified Body submissions and Health Canada Medical Device License applications.

2+ years of supervisory experience

Demonstrated experience developing and executing global/international regulatory strategy across multiple product lines or markets.

Working knowledge of US FDA regulatory frameworks for IVDs (510(k), De Novo, PMA) and CLIA/laboratory-developed test considerations.

Experience interfacing directly with regulatory authorities and/or Notified Bodies, including leading agency meetings and submission negotiations.

Strong knowledge of quality system frameworks relevant to IVDs (ISO 13485, ISO 14971, IEC 62304 for software as a medical device).

Excellent written and verbal communication skills, with experience presenting to senior leadership and external partners.

Proven people leadership or matrixed team leadership experience, with the ability to mentor and develop regulatory staff.

Preferred / Desired Qualifications

Direct experience supporting biopharma companion diagnostic co-development programs, including joint submissions or partner-facing regulatory strategy.

Clinical trial, clinical affairs, or clinical research regulatory experience (e.g., IDE submissions, clinical performance studies, GCP-related regulatory support) — desirable as the company builds out its clinical program.

Experience with additional international markets beyond IVDR/Health Canada (UKCA, TGA, NMPA, or other APAC/LATAM frameworks).

Familiarity with data privacy/genomic data considerations relevant to international markets (e.g., GDPR).

Working Conditions

Office environment, domestic and international travel required (estimated 10%) to support regulatory agency meetings, Notified Body audits, and biopharma partner engagements as needed.

#LI-Remote

Compensation

Salary Range: $144,600 - $217,000

Other compensation elements to include:

equity grant

bonus eligible

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