Regulatory Affairs Associate

Vaga não está no LinkedIn

🕒 Outubro 26

🍂 Massachusetts – Remoto

🍂 Massachusetts – Remote

💵 $85.000 / ano

⏰ Tempo Integral

🟢 Júnior

🟡 Pleno

🚔 Conformidade

👻 Score fantasma 3%

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• Aberta há 15 dias.
• As vagas desta empresa costumam ser preenchidas em 54 dias.

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Venus AI LLC

SiteLinkedInTodas as Vagas

1 - 10 funcionários

Fundada em 2023

💼 Consultoria

📣 Marketing

🤖 Inteligência Artificial

Consulting • Marketing • Artificial Intelligence

A Venus AI LLC é uma empresa focada em inteligência artificial que desenvolve e implementa soluções e serviços impulsionados por IA. Com ênfase na aplicação de aprendizado de máquina e técnicas orientadas por dados, a empresa ajuda as organizações a automatizar fluxos de trabalho, extrair insights de dados e melhorar a tomada de decisões. A Venus AI LLC pode oferecer consultoria, desenvolvimento de modelos e suporte à integração para clientes corporativos e de pequenas e médias empresas que buscam adotar tecnologias de IA.

Descrição

• Support global registrations and ensure medical devices produced by Venus Concept meet regulatory requirements in countries where devices are marketed • Execute regulatory strategies supporting registration and commercialization of medical devices • Prepare and submit technical files, design dossiers, and other regulatory filings for countries outside the United States • Coordinate with in-country regulatory partners and consultants to meet local requirements and maintain registrations in good standing • Provide regulatory guidance and support to cross-functional teams on global-market matters • Monitor changes in global regulatory requirements and industry standards and communicate updates internally • Ensure regulatory submissions are high quality, complete, and timely • Maintain and apply knowledge of international regulations, standards, and guidance documents • Assist in developing regulatory strategies for Venus Concept • Report to the Regulatory Affairs Manager

🎯 Requisitos

• Bachelor's degree in a scientific or technical discipline • 2-5 years of experience in regulatory affairs, with a focus on global medical device registrations • Knowledge of global regulations and standards for medical devices • Experience developing and executing global regulatory strategies • Experience preparing and submitting regulatory filings • Experience with technical documentation, including design dossiers, technical files, and other regulatory submissions • Excellent organization and attention to detail • Ability to work accurately in a fast-paced, ever-changing environment • Ability to work remotely • Excellent communication and interpersonal skills • Ability to work in a team environment and communicate with stakeholders across all levels of the organization • English language proficiency required • Professional experience proficiency with Microsoft Office required

🏖️ Benefícios

• Comprehensive benefits package starting on Day 1 • Medical insurance • Dental insurance • Vision insurance • Life insurance • 401(k) match • Equal opportunity, diversity, and inclusion commitment • Disability accommodations during each stage of the recruitment process • Remote work arrangement

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