Senior International Regulatory Affairs Specialist

Job Description

Job Description

Senior International Regulatory Affairs Specialist

Butterfly Network, Inc. (NYSE: BFLY) is driving a digital revolution in ultrasound imaging and sensing with its proprietary Ultrasound-on-Chip™ semiconductor technology and software solutions. Butterfly first proved its technology in the point-of-care ultrasound market – commercializing the world's first single-probe, whole-body portable ultrasound device, which is now on its best-selling, third-generation: Butterfly iQ3™. The Company combines its advanced hardware with cloud software and AI, an enterprise workflow solution (Compass AI™) and other offerings to drive adoption of affordable, accessible ultrasound. Butterfly also enables third-party development of imaging AI apps through Butterfly Garden™, its software development kit and AI partnership initiative.

In addition to its medical imaging products, Butterfly Embedded™ is the Company's Ultrasound-on-Chip™ licensing and co-development program designed to enable a new wave of ultrasound-enabled technologies across non-competitive healthcare markets and beyond. Through Butterfly Embedded™, partners can build and scale novel ultrasound applications powered by Butterfly's proprietary semiconductor chip and software platform. Butterfly's innovations have been recognized by Prix Galien USA, Fierce 50, TIME's Best Inventions and Fast Company's World Changing Ideas, among other achievements.

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 a Senior Specialist, International Regulatory Affairs at Butterfly Network, you will play a key role in enabling global market access for innovative, hardware and software medical devices.
You will support the execution of regulatory strategies and drive high-quality submissions across complex international markets, including APAC, MEA, LATAM, and MDSAP-participating countries.

This role requires a strong ability to translate evolving regulatory requirements—such as EU MDR 2017/745—into clear, actionable plans, while partnering cross-functionally to align regulatory expectations with fast-paced product and software development cycles.
You will assess the impact of product and software changes, navigate global regulatory pathways, and proactively identify risks and solutions to keep programs on track. Success in this role requires a highly organized, analytical, and self-driven regulatory professional who is comfortable operating in a dynamic environment, managing competing priorities, and contributing to the advancement of cutting-edge healthcare technologies on a global scale.

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

• Support execution of global regulatory strategies for Class II and higher medical devices, including Software in a Medical Device (SiMD)
• Contribute to and coordinate international regulatory submissions and registrations across APAC, MEA, LATAM, and MDSAP-participating countries
• Prepare and manage regulatory submission documentation, integrating cross-functional inputs and supporting timelines and deliverables
• Maintain product registrations, renewals, and amendments in accordance with country-specific requirements to support global market access
• Ensure compliance with global regulatory frameworks, including EU MDR 2017/745 and other applicable standards and regulations
• Partner with cross-functional teams (R&D, Quality, Clinical, Product, Commercial) to support alignment of regulatory requirements with product development and release timelines
• Assess regulatory impact of product and software changes and support required actions through established change control processes
• Utilize and maintain regulatory systems and tools (e.g., document management systems, regulatory submission platforms, and tracking tools) to support ongoing regulatory activities, submissions, and communications with regulatory bodies
• Coordinate with regulatory authorities, notified bodies, and in-country representatives to support submissions and resolve queries
• Communicate regulatory status, risks, and dependencies clearly and proactively; escalate issues and resource needs as appropriate
• Support post-market regulatory activities, including renewals, variations, and compliance maintenance while maintaining awareness of evolving global regulations and supporting audit readiness within a QMS-driven environment

Baseline skills/experiences/attributes:

• Bachelor's degree in a scientific, engineering, or related discipline (advanced degree preferred)
• At least 5+ years of progressive regulatory affairs experience in the medical device industry, including Class II or higher devices
• Demonstrated experience with software-enabled medical devices, including Software in a Medical Device (SiMD) and Software as a Medical Device (SaMD)
• Proven track record of supporting international regulatory submissions and market expansion, with hands-on experience across multiple regions, including: MDSAP countries, APAC, MEA and LATAM
• Strong working knowledge of global regulatory frameworks, including EU MDR 2017/745, and solid familiarity with international standards such as ISO 13485, ISO 14971, and IEC 62304
• Experience operating within a Quality Management System (QMS), with exposure to structured regulatory processes such as change control, design control, and lifecycle management
• Ability to manage multiple projects and competing priorities in a fast-paced environment
• Strong verbal and written communication and presentation skills, with the ability to communicate clearly and effectively in English
• Demonstrated ability to ethical judgment within regulatory frameworks and company policies
• Collaborative team player with a service-oriented mindset; flexible and proactive in adapting to changing business needs
• Independent thinker with the ability to identify problems and develop creative, compliant solutions.

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

• Experience in Artificial Intelligence/Machine Learning (AI/ML)
• Regulatory Affairs Certification (RAC).

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 $110,000 - $115,000 + bonus + equity + benefits. Actual pay is determined by multiple factors such as skills, qualifications, experience and market demand.

Candidates must be authorized to work in the United States. Butterfly Network will not provide immigration sponsorship of any kind for this position, including but not limited to H-1B, TN, O-1, L-1, or green card sponsorship (this includes applicants who are in the process of obtaining a green card), now or in the future.

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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