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. The company combines advanced hardware with cloud software and AI, enterprise workflow solutions, and third-party development platforms to enable affordable, accessible ultrasound globally. Innovations include the Butterfly iQ3™ portable ultrasound device and Butterfly Embedded™ licensing program for non-competitive healthcare markets.

About the role

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 translating 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.

Responsibilities

• 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 align 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).
• 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.

Requirements

• 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 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 in English.
• Demonstrated ability to exercise 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.

Nice-to-have

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

Values

• 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.

Location

This is a hybrid position based in Burlington, MA or New York City, NY. Butterfly offers a hybrid work model for most positions, with team members spending two or more days a week in the office to foster collaboration and creativity.

Benefits

• Comprehensive health insurance (medical, dental, and vision), with buy-up options and annual HSA contributions.
• Employee Assistance Program for emotional health and day-to-day support.
• 401k plan with company match.
• Employee Stock Purchase Plan (ESPP) for eligible employees.
• Unlimited Paid Time Off + 10 holiday days per year.
• Parental leave with additional support for primary caregivers transitioning back to work.
• Competitive salaried compensation, equity, and bonuses.

Pay

Estimated salary for this role is $110,000 - $115,000 + bonus + equity + benefits. Actual pay is determined by skills, qualifications, experience, and market demand.

Candidates must be authorized to work in the United States. Butterfly Network will not provide immigration sponsorship for this position.