Senior Manager, Regulatory Affairs

🕒 Yesterday

🇺🇸 United States – Remote

💵 $144.6k - $217k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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Adaptive Biotechnologies Corp.

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2009

🏥 Healthcare

🧬 Biotechnology

⚕️ Healthcare Insurance

💰 $125M Post-IPO Debt on 2022-09

Healthcare • Biotechnology • Healthcare Insurance

Adaptive Biotechnologies Corp. is a leader in immune-driven medicine, aiming to revolutionize disease detection and treatment. By utilizing the adaptive immune system, the company develops diagnostic and therapeutic solutions powered by its innovative Immune Medicine platform. They offer clinical diagnostics, particularly in Minimal Residual Disease (MRD) testing, and engage in drug discovery and therapeutic development through adaptive immunosequencing technologies. Their biopharma services support the progression of clinical trials and the development of transformative medicines. Adaptive Biotechnologies leverages the complex biology of the immune system, decoding it to advance medical science and improve patient outcomes.

📋 Description

• Lead development and execution of ex-US regulatory strategy for NGS-based IVD products. • Prioritize EU IVDR and Health Canada regulatory activities, including technical documentation, Notified Body engagement, PRRC responsibilities, EU Declaration of Conformity, and Medical Device License applications. • Build regulatory roadmaps for international expansion, including market-entry sequencing, gap assessments, and localization requirements. • Serve as primary contact and lead negotiator with international regulatory authorities and Notified Bodies. • Monitor global regulatory intelligence and translate changes into actionable strategy and process updates. • Own international technical files, design dossiers, and post-market surveillance/vigilance reporting obligations. • Lead regulatory activities for biopharma co-development and companion diagnostic partnerships. • Align CDx regulatory strategy with partner drug development timelines and support labeling, indications for use, and co-development agreements. • Maintain working knowledge of US FDA pathways and align global submission content, labeling, and change control assessments. • Support international clinical trial and clinical program regulatory planning. • Mentor junior Regulatory team members and provide technical and strategic guidance. • Collaborate with R&D, Quality, and cross-functional product development teams. • Communicate risk assessments and mitigation plans to leadership. • Contribute to budgeting, resourcing, and SOP development for international regulatory operations. • Domestic and international travel required, estimated at 10%.

🎯 Requirements

• 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. • Direct, hands-on experience with EU IVDR technical documentation and Notified Body submissions. • Experience with Health Canada Medical Device License applications. • 2+ years of supervisory experience. • 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. • Adaptive is not currently sponsoring candidates requiring work authorization support for this position.

🏖️ Benefits

• Equity grant • Bonus eligible • Adaptive benefits package (benefits at-a-glance referenced) • Affirmative Action and Equal Opportunity Employer • Reasonable accommodation support for disabled job seekers