Senior Regulatory Affairs Specialist
EBR Systems, Inc.
full-time
Posted on:
Location Type: Remote
Location: California • United States
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Salary
💰 $115,500 - $156,400 per year
Job Level
About the role
- 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!
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory strategiesregulatory assessmentstechnical documentationsubmissionsmedical device regulationsClass III medical devicescompliancestrategic planningregulatory inputregulatory approval
Soft Skills
collaborationindependenceactionable guidancecommunicationproblem-solvingorganizational skillsleadershipinterpersonal skillscritical thinkingtime management