Senior International Regulatory Affairs Specialist

Butterfly Network • Burlington, MA

1d • Hybrid

About The Position

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.

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 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.

Nice To Haves

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

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 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

Benefits

• Comprehensive health insurance, encompassing dental and vision coverage
• Option to buy up for enhanced health insurance coverage
• Health Savings Account (HSA) contributions
• Comprehensive Employee Assistance Program
• 401k plan and match
• Employee Stock Purchase Plan (ESPP)
• Unlimited Paid Time Off + 10 Holiday Days a Year
• Parental Leave
• Competitive salaried compensation
• Equity
• The opportunity to build a revolutionary healthcare product and save millions of lives!

What This Job Offers

• Job Type: Full-time
• Career Level: Senior