Job summary
Job post source
This job is directly from Butterfly Network, Inc.
Job overview
The Sr. Specialist, Regulatory Strategy at Butterfly Network plays a key role in developing and executing US regulatory strategic plans for innovative ultrasound products, ensuring compliance and timely regulatory submissions.
Responsibilities and impact
The role involves representing Regulatory on project teams, providing strategic guidance, preparing US FDA submissions, reviewing safety reports, communicating regulatory status, escalating risks, leading regulatory discussions, and tracking marketing materials.
Compensation and benefits
The position offers a salary range of $105,000 - $115,000 plus bonus, equity, comprehensive health insurance including dental and vision, 401k with match, Employee Stock Purchase Plan, unlimited PTO, parental leave, and other wellness benefits.
Experience and skills
Candidates need 5+ years in regulated industries, a Bachelor's in a scientific or technical field, experience with US FDA 510(k) or PMA submissions, strong communication and organizational skills, and knowledge in AI/ML, SaMD, or Digital Health; RAC certification is preferred.
Career development
Butterfly Network values personal and professional growth, offering opportunities to work on cutting-edge healthcare technology and participate in a collaborative, innovative environment.
Work environment and culture
The company culture emphasizes innovation, patient-centricity, teamwork, empowerment, growth, and action-oriented achievement with a hybrid work model fostering collaboration.
Company information
Butterfly Network is a pioneering medical imaging company known for its Ultrasound-on-Chip technology and handheld ultrasound devices, combining hardware with AI and software to democratize healthcare imaging globally.
Team overview
The candidate will join the Regulatory Affairs team, a talented and collaborative group focused on compliance and regulatory strategy for global product development.
Job location and travel
This hybrid role is based in Burlington, MA or New York City, NY, with an expectation of two or more days per week in the office in a collaborative workspace.
Unique job features
This role offers the unique opportunity to work on revolutionary handheld ultrasound technology integrating AI and software, impacting global healthcare delivery and regulatory strategy.
Company overview
Butterfly Network, Inc. is a digital health company that specializes in the development of handheld, portable ultrasound devices. Their flagship product, the Butterfly iQ, leverages semiconductor technology to provide affordable and accessible medical imaging solutions. The company generates revenue through the sale of these devices and associated software subscriptions, which offer cloud storage and advanced imaging capabilities. Founded in 2011, Butterfly Network aims to democratize medical imaging by making it more accessible to healthcare providers globally. Their innovative approach has the potential to revolutionize diagnostics, particularly in underserved areas.
How to land this job
Position your resume to emphasize your experience in regulatory strategy, particularly your knowledge of US FDA regulations and successful 510(k) or PMA submissions, as these are central to the role at Butterfly Network, Inc.
Highlight your expertise in medical device regulatory affairs, AI/ML, SaMD, or Digital Health compliance, showcasing your ability to interpret and communicate complex regulatory requirements to cross-functional teams.
Apply via multiple platforms including Butterfly Network’s official corporate careers page, LinkedIn, and other reputable job boards to maximize your application visibility.
Connect on LinkedIn with current Butterfly Network regulatory team members or product owners; start conversations by referencing recent Butterfly innovations like the Butterfly iQ ultrasound or asking about the regulatory challenges in digital health devices.
Optimize your resume for ATS by incorporating keywords such as 'US FDA 510(k)', 'regulatory submissions', 'medical device compliance', 'AI/ML', 'SaMD', and 'regulatory strategy' to ensure it passes automated screening tools effectively.
Utilize Jennie Johnson’s Power Apply feature to automate tailored applications, identify multiple application channels, and discover LinkedIn contacts for networking, freeing up your time to focus on interview preparation and skill enhancement.
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