Senior Regulatory Affairs Specialist – East Coast Preferred

🕒 Novembro 2

🏄 California – Remoto

🏄 California – Remote

💵 $89.000 - $119.000 / ano

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

🦅 Patrocina Visto H1B

Esta empresa já patrocinou vistos H1B no passado.

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Cordis

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

🏭 Manufatura

🏥 Saúde

💊 Farmacêutico

Manufacturing • Healthcare • Pharmaceuticals

A Cordis é líder mundial no desenvolvimento e na fabricação de tecnologia cardiovascular intervencionista, com mais de 60 anos de história na criação de produtos pioneiros. A empresa é especializada em produtos cardiovasculares de alta qualidade e minimamente invasivos, mantendo operações em mais de 60 países. Desde 2 de agosto de 2021, a Cordis opera como uma empresa independente e planeja investir US$ 300 milhões para acelerar a inovação em seu diversificado portfólio de produtos.

Descrição

• Assist, lead, and author documentation supporting high-quality regulatory submissions • Work with engineers, quality assurance, clinical, and other technical experts to develop compliance strategies • Prepare and manage global regulatory submissions for EU MDR, FDA IDE/PMA, LATAM, and APAC • Advise on regulatory strategies for development and marketed products • Lead process improvement initiatives to increase regulatory efficiency • Ensure ongoing compliance with QSR, ISO, and MDSAP requirements • Serve as regulatory representative on large projects and programs • Communicate regulatory requirements and regulatory impacts to project teams • Support global regulatory strategies for new and changing products • Interact directly with regulatory agencies • Prepare and submit PMAs, PMA-A/Ss, IDEs, Technical Files, and Change Notifications • Identify and develop Regulatory Affairs best practices • Support internal and external audits • Provide guidance to other regulatory team members • Support regulatory compliance activities across the business and corporation • Monitor new and changing regulatory and quality system requirements

🎯 Requisitos

• Strong experience with PMA authorship and submissions • Bachelor’s degree in Science, Pharmacology, or related field • 5+ years of regulatory experience in medical device or pharma • Proven success with Class III device submissions and CE Marking • Experience with Class III Medical Devices • Experience with IDE, PMA, Design Dossier/Change Notifications, and Shonin Applications • Fluent in English • US work authorization required • Must not require sponsorship for a work-authorized visa • Strong written, organizational, verbal, and project management skills • Ability to work effectively in cross-functional teams • Ability to manage multiple competing priorities and programs with minimal oversight • Strong technical skills, critical thinking, and sound decision-making • Leadership or mentorship experience in regulatory affairs preferred • Global regulatory knowledge across multiple regions preferred • Experience with coronary/peripheral products preferred • Experience with combination products preferred

🏖️ Benefícios

• Equal opportunity employment • Inclusive, equitable, and welcoming working and learning environments • Talent Community access to company news, career opportunities, and events

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