Senior Regulatory Affairs Specialist

🕒 Março 20

🏄 California – Remoto

🏄 California – Remote

💵 $115.500 - $156.400 / ano

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

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EBR Systems, Inc.

SiteLinkedInTodas as Vagas

51 - 200 funcionários

A EBR Systems, Inc. está empenhada em oferecer tratamento superior para milhões de pacientes que sofrem de doenças do ritmo cardíaco, desenvolvendo terapias seguras, clinicamente superiores, econômicas e confiáveis, utilizando estimulação cardíaca sem fio. O produto inicial da empresa, o sistema WiSE® CRT, é um dispositivo médico pioneiro, desenvolvido para superar as limitações da Terapia de Ressincronização Cardíaca (CRT) tradicional em pacientes com insuficiência cardíaca, eliminando a necessidade de um eletrodo no ventrículo esquerdo do coração e as complicações associadas a esse eletrodo. ATENÇÃO: Dispositivo em Investigação. Limitado pela lei dos EUA ao uso investigacional somente.

Descrição

• Represents the Regulatory Affairs department in assigned project teams and provides regulatory input in accordance with established timelines to meet corporate objectives. • Develops and executes sound regulatory strategies to support business goals. • Oversees and ensures compliance with state, federal, and international medical device regulations and overall regulatory departmental objectives for new and existing products. • Independently assesses product and manufacturing changes and develops well-justified regulatory assessments for each global market. • Develops, prepares, and submits high quality technical documentation/submissions for regulatory approval in the US and other international regions.

🎯 Requisitos

• Bachelor's degree in a scientific, engineering, or technical discipline is required. • Minimum 4 years of directly relevant Regulatory Affairs experience within the medical device or other regulated industry. • An advanced degree may supplement some professional experience. • Experience with Class III medical devices is preferred. • Strong knowledge of US and international medical device regulations. • Ability to interpret regulatory requirements and provide actionable guidance to cross-functional team members. • Experience with successful submissions and strategic planning. • Ability to work in collaborative and independent work situations and environments with minimal supervision.

🏖️ Benefícios

• Medical, dental, and vision insurance provided at no cost for employee-only coverage • 401(k) matching plan • Paid Time Off – starting at 3 weeks per year • Competitive salary with opportunities for career growth • Employee stock options • Life & AD&D and long term disability insurance • Education assistance • Voluntary commuter benefits and pet insurance • Meaningful work and much more!