Senior Regulatory Consultant

🕒 Outubro 1

🌐 Estados Unidos, Bélgica – Remoto

🇺🇸 Estados Unidos – Remoto (EUA) 🇧🇪 Bélgica – Remoto

💵 $101.600 - $197.500 / ano

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

👻 Score fantasma 0%

O que significa: quão provável esta vaga está aberta sem contratação ativa.Como ler: 60% ou mais significa que achamos que é uma vaga fantasma. Pontuações mais baixas preocupam menos.Como pontuamos: tempo em aberto, republicações, vagas abertas vs tamanho do time, rapidez para fechar vagas, e se o salário está divulgado.Observação: é uma estimativa de dados públicos, não um julgamento da empresa. Vagas reais podem ter pontuação alta, então use como uma dica, não como um fato.

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NAMSA

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

Fundada em 1967

🏥 Saúde

🏭 Manufatura

📦 Logística

Healthcare • Manufacturing • Logistics

A NAMSA é líder global em testes e pesquisas de dispositivos médicos, oferecendo serviços abrangentes de consultoria, pesquisa pré-clínica, pesquisa clínica e testes para fabricantes de dispositivos médicos e IVD em todo o mundo. Com uma equipe de mais de 1. 400 especialistas e laboratórios de última geração na América do Norte, Europa e Ásia, a NAMSA realiza testes extensivos para garantir a segurança, eficácia e conformidade de dispositivos médicos. A empresa oferece consultoria estratégica sobre submissões regulatórias e estratégias de mercado, ajudando os clientes a navegar por cenários regulatórios complexos de forma eficiente e eficaz. Fundada em 1967, a NAMSA é confiada pelos fabricantes para fornecer serviços de alta qualidade desde o conceito até a comercialização.

Descrição

• Lead the development and execution of global regulatory strategies for medical devices, in vitro diagnostics, combination products, and related technologies across all stages of product development • Serve as the primary regulatory consultant for clients, providing scientific, technical, and strategic guidance to support regulatory approvals, market access, and commercialization objectives • Prepare, review, and support regulatory submissions and interactions with health authorities and conformity assessment bodies, including FDA, Health Canada, and other global regulators • Develop and review regulatory assessments, technical documentation, clinical and preclinical strategies, testing plans, and supporting evidence packages • Lead cross-functional project teams and collaborate with clinical, quality, biostatistics, reimbursement, and laboratory experts to deliver integrated client solutions • Interpret regulatory requirements, assess regulatory impact, and recommend practical, risk-based pathways to market • Manage multiple client engagements simultaneously, ensuring high-quality deliverables, timelines, budgets, and proactive communication of project risks and issues • Support business development activities by engaging with prospective clients, defining project scope, contributing to proposals, estimating effort, and identifying opportunities for additional NAMSA services • Mentor and coach consultants and associates, providing technical leadership and contributing to colleagues' professional development • Contribute to NAMSA's thought leadership through conference presentations, webinars, publications, standards participation, white papers, and other scientific or marketing initiatives • Drive continuous improvement of consulting processes, service delivery, and regulatory best practices • Maintain expert knowledge of global medical device regulations, standards, guidance documents, and industry trends • Travel approximately 5 to 10% of the time

🎯 Requisitos

• 7+ years of medical device regulatory experience, including strategic leadership of product development programs • Prior FDA, regulatory authority, or medical device industry experience required • Expertise in one or more areas, including regulatory affairs, clinical strategy, non-clinical testing, engineering, combination products, or IVDs • Strong knowledge of global medical device regulations, standards, and quality systems, including FDA, EU MDR/IVDR, ISO 13485, MDSAP, GCP, GLP, GMP, NMPA, and PMDA • Demonstrated ability to develop regulatory strategies, assess regulatory impact, and support interactions with global regulatory agencies • Strong analytical, problem-solving, communication, writing, and presentation skills • Ability to lead cross-functional teams, manage multiple priorities, and deliver high-quality results within timelines and budgets • Commitment to continuous learning and professional development in emerging regulatory and industry topics • Advanced degree (Master's, PhD, or equivalent) in science, engineering, business, or a related field preferred

🏖️ Benefícios

• Professional development and continuous learning opportunities • Mentoring and coaching opportunities • Reasonable accommodations for individuals with disabilities • Equal employment opportunity • Pre-employment background and drug screen processes aligned to local, state, and federal laws