Senior International Regulatory Affairs Specialist Company Description 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! Job Description 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.

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.

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

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 reg

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