Senior Regulatory Affairs Specialist

🕒 Outubro 30

🌐 Estados Unidos, Canadá – Remoto

🇺🇸 Estados Unidos – Remoto (EUA) 🇨🇦 Canadá – Remoto

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

👻 Score fantasma 12%

O que significa: a chance de ninguém estar realmente contratando para esta vaga.Como ler: 60% ou mais significa que achamos que é uma vaga fantasma. Pontuações mais baixas preocupam menos.Por que essa pontuação:

• Aberta há 11 dias.
• Sem salário divulgado.

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Function Health

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

Fundada em 2022

🏥 Saúde

👥 B2C

🔥 Investimento no último ano

💰 $450.000.000 Debt Financing em 2026-07

Healthcare • B2C

A Function Health é uma empresa de saúde voltada para o consumidor, que oferece serviços abrangentes de exames diagnósticos e exames de imagem por assinatura. Por US$ 365/ano, disponibiliza mais de 160 exames laboratoriais (realizados em mais de 2. 000 laboratórios ou por meio de coleta móvel) e acesso a exames de imagem por MRI/CT, com resultados explicados por médicos e suporte de IA e ferramentas para compartilhá-los com profissionais de saúde. O serviço é elegível para uso com HSA/FSA e prioriza a detecção precoce e o acompanhamento longitudinal de centenas a milhares de condições por meio de exames recorrentes e interpretação clínica.

Descrição

• Partner with product managers from the requirements stage to set the regulatory path for new features • Review member-facing claims, user experience, and AI-generated outputs against general wellness, clinical decision support, and medical device boundaries • Prepare regulatory launch reviews and supporting documentation for sign-off • Author and coordinate sections of 510(k), De Novo, and Pre-Submission packages • Support design control documentation, risk management, and verification and validation evidence planning • Support regulatory strategy, determinations, and submissions for international markets, such as the EU and UK • Help maintain quality management system elements supporting regulatory work, including document control, design history files, CAPA input, and audit readiness • Conduct regulatory change assessments for software, model, and labeling updates to cleared products • Maintain submission trackers, device determinations, change assessment logs, and agency correspondence • Monitor FDA guidance and policy on digital health and AI-enabled devices, and translate it into clear direction for teams • Build lightweight regulatory processes and templates for product and research teams • Work across lab testing, imaging, and AI-enabled products • Report to the Principal Regulatory Affairs Specialist / Director, Regulatory Affairs

🎯 Requisitos

• 5+ years of regulatory affairs experience with medical devices, software as a medical device (SaMD), or diagnostics • Bachelor's degree in engineering, life sciences, or a related technical field • Hands-on experience with 510(k), De Novo, or Pre-Submission work, including preparing submission content • Working knowledge of FDA device regulations and guidance, including general wellness, clinical decision support software, and AI-enabled device software, plus ISO 13485, ISO 14971, and IEC 62304 • Familiarity with international medical device regulations, such as EU MDR and UK MHRA requirements • Working knowledge of quality management system requirements under ISO 13485 and 21 CFR Part 820 (QMSR) • Experience reviewing labeling, marketing, and in-product claims • Clear writing, and the ability to turn regulatory requirements into practical guidance for product, engineering, and clinical teams • Comfortable using AI tools to speed up regulatory work, with the judgment to verify and correct their outputs • A bias toward action, and comfort prioritizing across several concurrent projects in a fast-moving environment • AI/ML-enabled device experience, including predetermined change control plans and performance evaluation • Laboratory-developed tests, CLIA, or in vitro diagnostics • Imaging devices • Device cybersecurity and post-market obligations, including complaint handling and adverse event reporting • IRB submissions and oversight of human subjects research • MDSAP audit experience • RAC certification and experience at a startup or consumer health company

🏖️ Benefícios

• Competitive Base Salary • Stock options • Comprehensive health, dental, and vision plans for you and your family • Flexible work environment • Team off-sites and wellness initiatives • Competitive vacation policy • A culture that emphasizes continuous learning and personal growth • Flexible working hours • Dynamic work environment where creativity and innovation are encouraged

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