Butterfly Network
Senior International Regulatory Affairs Specialist
New York, NY Office · Senior
Work authorization required$110k-$115kDetected 61 days ago
Machine LearningSparkCybersecurityUnityFDA RegulatoryMedical DevicesRadiologyCommunicationCollaborationOrganizational SkillsRegulatory Affairs
About the role
- 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™.
- Butterfly also enables third-party development of imaging AI apps through Butterfly Garden™, its software development kit and AI partnership initiative.
- 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.
Responsibilities
- Prepare and manage regulatory submission documentation, integrating cross-functional inputs and supporting timelines and deliverables
- 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
- 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
- Maintain product registrations, renewals, and amendments in accordance with country-specific requirements to support global market access
- Partner with cross-functional teams (R&D, Quality, Clinical, Product, Commercial) to support alignment of regulatory requirements with product development and release timelines
Requirements
- 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
- These include: adhering to all company security policies and procedures, utilize provided company assets securely, and complete all required security awareness training programs.
- adhering to all company security policies and procedures, utilize provided company assets securely, and complete all required security awareness training programs.
Skills
- Bachelor's degree in a scientific, engineering, or related discipline (advanced degree preferred)
- At least 7+ years of progressive regulatory affairs experience in the medical device industry, including Class II or higher devices
- 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
- Experience in Artificial Intelligence/Machine Learning (AI/ML)
- Regulatory Affairs Certification (RAC).
- Senior International Regulatory Affairs Specialist
- Company Description
- Let's build something extraordinary together!
Compensation
- Our estimated salary for this role is $110,000 - $115,000 NYC, + bonus + equity + benefits. Actual pay is determined by multiple factors such as skills, qualifications, experience and market demand.
Benefits
- 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
- Equity - we want every employee to be a stakeholder
- The opportunity to build a revolutionary healthcare product and save millions of lives!
- Support execution of global regulatory strategies for Class II and higher medical devices, including Software in a Medical Device (SiMD)
Company info
- Our mission is THE mission.
Equal opportunity
- Butterfly Network is an equal opportunity employer.
- All your information will be kept confidential according to EEO guidelines.
Visa & Work Authorization
- 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.
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This listing is sourced directly from Butterfly Network's careers page and normalized into a canonical job model.