Butterfly Network
Senior International Regulatory Affairs Specialist
New York, NY Office · Senior
No sponsorship$110k-$115kDetected 7 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
- Candidates must be authorized to work in the United States.
- 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
- Candidates must be authorized to work in the United States.
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This listing is sourced directly from Butterfly Network's careers page and normalized into a canonical job model.