Senior Regulatory Affairs Specialist

🕒 March 20

🏄 California – Remote

🏄 California – Remote

💵 $115.5k - $156.4k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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EBR Systems, Inc.

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51 - 200 employees

EBR Systems, Inc. is driven to deliver superior treatment for millions of patients suffering from cardiac rhythm diseases by developing safe, clinically superior, cost-effective, and reliable therapies using wireless cardiac stimulation. The company’s initial product, the WiSE® CRT System, is a first-of-its-kind medical device developed to overcome the limitations of traditional Cardiac Resynchronization Therapy (CRT) in heart failure patients by eliminating the need for a lead to the heart’s left ventricle and the associated complications of that lead.

📋 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.

🎯 Requirements

• 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.

🏖️ Benefits

• 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!