EBR Systems, Inc. · 1 month ago
Principal Regulatory Affairs Specialist
Sunnyvale,CA,US
Full-time
Onsite
Senior Level, Lead/Staff
$150K/yr - $180K/yr
7+ years expEBR Systems, Inc. is a pioneering company in cardiac technology, known for developing the world’s first FDA approved, leadless left ventricular endocardial pacing device for heart failure. The Principal Regulatory Affairs Specialist will lead regulatory projects, ensure compliance with medical device regulations, and mentor team members while driving regulatory strategies to support business objectives.
BiotechnologyHealth CareMedicalMedical Device
Responsibilities
Represents RA department in assigned project meetings and provides regulatory guidance to ensure adherence with global regulatory requirements as appropriate
In conjunction with project teams and international partners, evaluates possible pathways to marketing authorization and recommends pathway that appropriately weighs the probability of success with potential risks to the business
With minimal Regulatory Affairs management oversight, develops and executes sound regulatory strategies to support business goals
Independently assesses product and manufacturing changes and develops well-justified regulatory assessments for each global market
Reviews and approves document change orders, advertising and promotional material, manufacturing nonconformances, technical documents, test protocols and reports, risk management documents, labeling documents, and other documents as a key member of assigned project teams and ongoing sustaining support
Directly interacts with regulatory bodies in the US and/or international regions in a respectful, professional manner to ensure projects remain on track and issues are identified and resolved as expediently as possible
Develops, prepares, and submits high quality technical documentation/submissions for regulatory approval in the US and other international regions
Establishes timelines, manages sub-team meetings relevant to the regulatory processes, and ensures timely execution
Prepares reports for management and develops metrics and proposals for regulatory process improvements
Represents the Regulatory Affairs function in internal and external audits
Serves as regulatory subject matter expert for areas related to project responsibilities
Provides support for external audit activities as needed
Proactively maintains up-to-date knowledge on applicable domestic and international regulatory requirements and effectively communicates requirements to project teams and management
Assign and oversee completion of prioritized tasks to junior Regulatory Affairs team members, as appropriate
Updates departmental procedures as required
Other duties as assigned
Qualification
Required
Bachelor's degree in a scientific, engineering, or technical discipline is required
Minimum 7 years of directly relevant Regulatory Affairs experience within the medical device or other regulated industry
Strong knowledge of US and international medical device regulations
Ability to interpret regulatory requirements and provide actionable guidance to cross-functional team members
Demonstrated experience with successful submissions and strategic planning
Effectively uses all mediums of communication as appropriate, presents well to groups, actively listens, and continuously identifies opportunities to build communication skills
Actively works together with formal and informal team members to build relationships and achieve team goals
Effectively manages multiple assignments and prioritizes work to ensure timely completion of work within scope
Continuously builds functional and technical expertise and proactively applies that technical expertise in progressively broader scope
Focuses on results, takes initiative without direction, takes ownership for all work within scope, builds relationships and works across departments, functions, or areas of responsibility
Actively seeks to understand perspectives and interpersonal needs and expectations of others at all levels, builds self-awareness, flexes personal style appropriately, and works through conflicts constructively and appropriately
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
Ability to work in collaborative and independent work situations and environments with minimal supervision
Willingness and able to travel approximately 10% of the time
Required to stand, walk and sit; talk or hear; use hands to finger, handle or feel objects or controls; reach with hands and arms
Required to stoop, kneel, bend, crouch and lift up to 20 pounds
Specific vision abilities required by this job include close vision, distance vision, depth perception, color vision and the ability to adjust focus
Subject to extended periods of sitting and/or standing, vision to monitor, and moderate noise levels
Preferred
Experience with Class III active implantable medical devices
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
Weekly company lunches and occasional happy hour events
Company
EBR Systems, Inc.
EBR Systems, Inc.
51-200 employees
H1B Sponsorship
EBR Systems, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (1)
2023 (1)
2022 (1)
2021 (2)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$248.68MKey Investors
Thomas FogartyDelphi Ventures
2025-06-18Post Ipo Equity· $13M
2025-05-22Post Ipo Equity· $35.83M
2021-07-29IPO
Leadership Team
Allan Will
Executive Chair of the Board of Directors (previously CEO)
John McCutcheon
President and CEO
Recent News
Morningstar.com
2025-10-14
Company data provided by crunchbase