Senior Regulatory Affairs Specialist

🕒 il y a 3 mois

🏄 California – Distant

🏄 California – Remote

💵 $115 500 - $156 400 / an

⏰ Temps Plein

🟠 Senior

🚔 Conformité

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EBR Systems, Inc.

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51 - 200 employés

EBR Systems, Inc. est déterminée à offrir un traitement supérieur à des millions de patients souffrant de maladies du rythme cardiaque en développant des thérapies sûres, cliniquement supérieures, rentables et fiables utilisant la stimulation cardiaque sans fil. Le produit initial de l'entreprise, le système WiSE® CRT, est un dispositif médical unique en son genre, conçu pour surmonter les limites de la thérapie de resynchronisation cardiaque (CRT) traditionnelle chez les patients atteints d'insuffisance cardiaque, en éliminant la nécessité d'une sonde vers le ventricule gauche du cœur et les complications associées à cette sonde.

Description

• 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.

🎯 Exigences

• 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.

🏖️ Avantages

• 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!