Job summary
Job post source
This job is directly from Butterfly Network, Inc.
Job overview
The Senior Regulatory Affairs Specialist at Butterfly Network plays a crucial role in supporting international regulatory submissions and ensuring compliance for innovative ultrasound technology globally.
Responsibilities and impact
The role involves preparing and managing regulatory submissions, maintaining product registrations, coordinating cross-functional tasks, communicating registration status, anticipating regulatory challenges, and supporting audits to ensure timely regulatory approvals.
Compensation and benefits
The position offers a salary range of $100,000 to $110,000 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 at least 3 years in a regulated industry, a bachelor's degree in a relevant scientific or technical field, experience with international medical device regulations like EU MDR, strong communication and organizational skills, and preferably Regulatory Affairs Certification or AI/ML experience.
Career development
The company values personal and professional growth, offering opportunities to work on cutting-edge medical imaging technology in a collaborative environment.
Work environment and culture
Butterfly Network promotes a patient-centric, innovative, and collaborative culture with a hybrid work model emphasizing teamwork, creativity, and employee well-being.
Company information
Butterfly Network is a pioneering health-tech company known for its Ultrasound-on-Chip technology and handheld ultrasound devices, recognized for innovation and transforming medical imaging.
Team overview
The candidate will join the international Regulatory Affairs team, which is described as talented and fun-loving, focused on global compliance and regulatory best practices.
Job location and travel
This hybrid role is based in Burlington, MA or New York City, NY, with a flexible schedule requiring two or more days per week in the office.
Application process
Candidates must be legally authorized to work in the US without visa sponsorship; Butterfly Network does not accept agency resumes and follows equal opportunity employment practices.
Unique job features
The role offers the chance to work on revolutionary healthcare products, contributing to global health impact with advanced ultrasound technology and regulatory innovation.
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
Tailor your resume to emphasize your experience in preparing and managing international regulatory submissions, especially for medical devices, highlighting familiarity with EU MDR, MDSAP, APAC, MEA, and LATAM regulations.
Showcase your ability to coordinate cross-functional teams, manage multiple projects, and communicate regulatory risks and timelines effectively, as these are key responsibilities for the Senior Regulatory Affairs Specialist role.
Apply through multiple channels including Butterfly Network's corporate careers page and LinkedIn to maximize your application visibility and ensure you don't miss any updates or opportunities.
Connect with current Regulatory Affairs team members or professionals in Butterfly Network's international regulatory division on LinkedIn; start conversations with ice breakers like commenting on Butterfly's innovation in Ultrasound-on-Chip technology or asking about their experience navigating global regulatory challenges.
Optimize your resume for ATS by incorporating keywords from the job description such as 'regulatory submissions,' 'international regulatory requirements,' 'EU MDR,' 'medical devices,' 'cross-functional coordination,' and 'risk management' to pass initial automated screenings.
Utilize Jennie Johnson's Power Apply feature to automate tailoring your resume, identify the best application platforms, and discover LinkedIn contacts to network with, freeing up your time to prepare for interviews and deepen your industry knowledge.
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