Senior Director, Regulatory Affairs – Product Development

🕒 Setembro 23

🇺🇸 Estados Unidos – Remoto (EUA)

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

👻 Score fantasma 10%

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Artivion, Inc.

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

Fundada em 1984

🏥 Saúde

🏭 Manufatura

💼 Consultoria

Healthcare • Manufacturing • Consulting

A Artivion, Inc. é uma empresa de tecnologia médica focada no desenvolvimento, fabricação e comercialização de dispositivos cirúrgicos e produtos de biomateriais centrados em aorta e coração. A empresa produz válvulas cardíacas (On-X), sistemas de enxerto de stent arco aórtico e tóraco-abdominal, próteses híbridas (AMDS), aloenxertos e tecidos criopreservados, adesivos cirúrgicos (BioGlue) e ferramentas auxiliares para cirurgia vascular e cardíaca. A Artivion trabalha com cirurgiões cardíacos e vasculares, conduzindo ensaios clínicos e submissões regulatórias para avançar na segurança e eficácia dos dispositivos, atendendo hospitais e centros cirúrgicos globalmente.

Descrição

• Establish, approve, and oversee global regulatory strategies for emerging technology, product development, product registrations, lifecycle management, and market access • Lead portfolio-level regulatory planning for complex high-risk devices, including pathways, claims, labeling, evidence, timelines, resources, and approval risk • Serve as senior Regulatory Affairs representative to executive leadership, program governance, and cross-functional product development teams • Advise on regulatory risk, tradeoffs, and go/no-go decisions • Influence and manage emerging and acquired technology opportunities and support integrations • Oversee timely, high-quality submissions to global regulatory agencies, including FDA pre-submissions, IDE, PMA, 510(k), PMA supplements, EU MDR technical documentation, CE Marking, deficiency responses, and international registrations • Lead and negotiate regulatory authority interactions, including FDA meetings, notified body reviews, competent authority engagement, advisory panel preparation, formal correspondence, and deficiency resolution • Advise on clinical evidence strategies supporting global approvals • Interpret evolving global medical device regulations, standards, and guidance; assess enterprise impact and drive implementation plans • Support global compliance programs • Partner with R&D, Clinical, Quality, Operations, Supply Chain, Marketing, Commercial, and Legal teams • Direct regulatory assessments for new technologies, design changes, labeling, claims, product discontinuations, partnerships, and business development opportunities • Contribute to commercial plans and regional/corporate objectives • Build, manage, mentor, and succession-plan the Regulatory Affairs organization; set goals, allocate resources, manage budgets, and establish metrics • Provide senior regulatory leadership for audits, inspections, escalations, field actions, and compliance issues

🎯 Requisitos

• Bachelor's degree required in science, engineering, life sciences or related discipline • Minimum 12 years of experience in regulatory affairs or the medical device industry with bachelor's degree, including significant leadership experience, OR minimum 10 years of experience with engineering degree and master's degree, including significant leadership experience • Extensive experience defining and executing global regulatory strategies for Class II/III and high-risk medical devices across new product development and lifecycle management • Proven success leading or substantially influencing successful submissions and approvals, including IDE, PMA, HDE, PMA supplements, EU MDR technical documentation/CE Marking, ANVISA, PMDA, and Health Canada registrations • Expertise in global medical device regulations, particularly US FDA, EU MDR, Canada, Latin America, and Asia Pacific requirements • Experience leading interactions and negotiations with FDA, notified bodies, and global regulatory authorities • Ability to align regulatory strategy with clinical evidence generation, pivotal studies, benefit-risk assessments, labeling, claims, and commercialization plans • Experience with US FDA QMSR/21 CFR Part 820, ISO 13485, ISO 14971, design controls, and related medical device standards • Advanced analytical thinking and understanding of engineering, physiology, device design, medical device use, and software/digital components • Proven program and portfolio management skills • Personnel development, succession planning, budget/resource management, and organizational design skills • High ethical standards, sound judgment, and ability to lead through ambiguity while maintaining compliance, quality, and patient safety focus