Sr. Specialist, Regulatory Strategy

At Butterfly Network, we’re leading a digital revolution in medical imaging, transforming an industry that has long relied on bulky, analog systems. With our proprietary Ultrasound-on-Chip™ technology, we’re democratizing healthcare by shifting ultrasound from the expensive, stationary systems of the past to the connected, mobile, and software-enabled platforms of today.  In 2018, we launched the world’s first handheld, whole-body ultrasound, Butterfly iQ – followed by iQ+ in 2020 and iQ3 in 2024, each more powerful than the last.

Our innovation doesn’t stop at hardware. Butterfly combines our advanced device with intelligent software, AI, services, and education to drive adoption of affordable, accessible imaging. Our technology is proving to help clinicians, clinics, and hospitals enhance care, cut costs, and expand imaging access. We’ve been recognized by Prix Galien USA, Fierce 50, TIME’s Best Inventions, Fast Company’s World Changing Ideas, among other awards.

We’re a team of bold thinkers, problem-solvers, and innovators ready to shape the future of medical imaging. Let’s build something extraordinary together!

As Butterfly continues to expand its product offerings, this is an exciting opportunity to play an integral role in the development of innovative and disruptive ultrasound technology that delivers advanced medical imaging throughout the world. Be a key member of our talented and fun-loving Regulatory Affairs team working to ensure Butterfly establishes best practices in compliance and regulatory requirements on a global scale. 

The Senior Specialist, Regulatory Strategy (depending on experience, Manager is an option) will be responsible for the development, execution, and communication to Regulatory upper management and to program teams about US regulatory strategic plans for products on Butterfly’s roadmap. 

The Senior Specialist, Regulatory Strategy will also be responsible in preparing regulatory submissions for our Butterfly Ultrasound Systems and help coordinate, track, and communicate the execution of cross-functional tasks to ensure timely delivery of regulatory documents for submission to regulatory authorities. Come join an organization that values its people’s personal and professional growth, and together we can help build the future of healthcare.

As part of our team, your core responsibilities will be: 

• Represent Regulatory on project teams and provide strategic regulatory guidance to product owners/teams in line with commercial objectives.
• Utilize medical device, AI/ML, SaMD, or Digital Health knowledge of requirements to strategically interpret, plan, and communicate with cross functional teams.
• Provide a critical analysis of risks and issues to ensure planned device development activities comply with regulatory guidelines and projects stay on track.
• Build comprehensive regulatory submissions primarily for US FDA filings based on input from cross-functional teams and manage the execution of timelines and regulatory deliverables. 
• Critically review complex product safety and/or V&V reports for scientific merit and regulatory appropriateness.
• Clearly and concisely communicate registration status and provide early visibility into risks/issues to enable timely action.
• Escalate submission risks, resource needs, priority conflicts, etc. to appropriate program and functional managers.
• Help lead regulatory discussions on US requirements, including discussions with the US FDA, and provide feedback to senior regulatory management and project teams.
• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
• Help track advertising, promotional, and labeling materials and ensure timely delivery of marketing assets. 
• Maintains a knowledge base in domestic regulatory policy, regulation and initiatives.

Baseline skills/experiences/attributes:

• 5+ years of experience in a regulated industry.
• Bachelor's degree in Scientific, Engineering, Regulatory, or core Life Science discipline. M.S. in a technical area or M.B.A. is preferred.
• Experience with successful preparation and submission of US FDA 510(k)s and/or PMAs. 
• Excellent understanding of US FDA regulations. 
• Strong verbal and written communication and presentation skills, with the ability to speak and write clearly and convincingly in English.
• Strong organizational, analytical, and strategic thinking skills.
• Exercises good and ethical judgment within policy and regulations.
• A team player and collaborator with a service-oriented approach who is also flexible and proactive towards changing needs.
• Experience in Artificial Intelligence/Machine Learning (AI/ML), Software as a Medical Device (SaMD), or Digital Health.

Ideally, you also have these skills/experiences/attributes (but it’s ok if you don’t!):

• Regulatory Affairs Certification (RAC).

Values

Innovation is what we do. Our values are how we make it happen. Butterflies are and believe in…

• Patient-Centric Innovators: Our mission is THE mission.
• Empowered to Impact: Every voice matters.
• One Team, One Goal: Unity fuels progress.
• Growth Champions: We embrace challenges.
• Action-Oriented Achievers: We follow through, every time.

Butterfly offers a hybrid work model for most positions, with team members spending two or more days a week in the office. While flexibility is key, we value in-person connections that spark creativity and teamwork. Our offices are designed for collaboration, with comfortable workspaces, stocked kitchens, and opportunities to connect with peers.

This is a hybrid position that can be based in Burlington, MA or New York City, NY

• Comprehensive health insurance, encompassing dental and vision coverage, is provided to all our employees. As a health-tech company, we prioritize the well-being of our teams. Additionally, employees have the option to buy up for enhanced health insurance coverage. We also contribute to Health Savings Account (HSA) accounts for all enrolled employees on an annual basis.
• Comprehensive Employee Assistance Program - we provide access to tools and resources to support your emotional health and day-to-day needs.
• 401k plan and match - we facilitate your retirement goals.
• Eligible employees will have the opportunity to participate in Employee Stock Purchase Plan (ESPP)
• Unlimited Paid Time Off + 10 Holiday Days a Year - recharge and come back ready to make an impact
• Parental Leave - we aim to provide our employees with time to bond with their growing family, along with additional support for primary caregivers to help transition back to work 
• Competitive salaried compensation - we value our employees and show it 
• Equity - we want every employee to be a stakeholder
• The opportunity to build a revolutionary healthcare product and save millions of lives! 

Our estimated salary for this role is between $105,000 - $115,000 + bonus + equity + benefits. Actual pay is determined by multiple factors such as skills, qualifications, experience and market demand.

For this role, we are only considering candidates who are legally authorized to work in the United States and who do not now or in the future require sponsorship for employment visa status.

Butterfly Network does not accept agency resumes.

Butterfly Network is an E-Verify Company. 

Butterfly Network is an equal opportunity employer.  Regardless of race, traits associated with race, color, ancestry, religion, gender, national origin, sexual orientation, age, citizenship, marital status, disability or Veteran status. All your information will be kept confidential according to EEO guidelines.

Butterfly requires security adherence responsibilities from all employees. These include:  adhering to all company security policies and procedures, utilize provided company assets securely, and complete all required security awareness training programs. Safeguarding company data and systems from unauthorized access, modification, or destruction, contributing to the overall security posture of the organization. Immediately reporting any suspected or actual security incidents, including phishing attempts, malware infections, or unauthorized access, following the established incident response procedures.

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