Senior Manager, Regulatory Affairs

🕒 Setembro 30

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $144.600 - $217.000 / ano

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

👻 Score fantasma 0%

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Adaptive Biotechnologies Corp.

SiteLinkedInTodas as Vagas

501 - 1000 funcionários

Fundada em 2009

🏥 Saúde

🧬 Biotecnologia

⚕️ Seguro de Saúde

💰 $125.000.000 Post-IPO Debt em 2022-09

Healthcare • Biotechnology • Healthcare Insurance

A Adaptive Biotechnologies Corp. é líder em medicina guiada pelo sistema imunológico, com o objetivo de revolucionar a detecção e o tratamento de doenças. Utilizando o sistema imunológico adaptativo, a empresa desenvolve soluções diagnósticas e terapêuticas impulsionadas por sua inovadora plataforma de Medicina Imunológica. Oferecem diagnósticos clínicos, particularmente em testes de Doença Residual Mínima (MRD), e se envolvem na descoberta de medicamentos e desenvolvimento terapêutico através de tecnologias de imunosequenciamento adaptativo. Seus serviços para biofarmacêuticas apoiam a progressão de ensaios clínicos e o desenvolvimento de medicamentos transformadores. A Adaptive Biotechnologies aproveita a complexa biologia do sistema imunológico, decodificando-a para avançar na ciência médica e melhorar os resultados para os pacientes.

Descrição

• 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%.

🎯 Requisitos

• 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.

🏖️ Benefícios

• 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