Senior International Regulatory Affairs Specialist

Butterfly Network

Burlington, MA, US
Competitive salaried compensation; equity provided...
On-site
5+ years medical device regulatory experience
Eu mdr 2017/745 knowledge
International submission management apac mea latam
This role enables global market access for innovative hardware and software medical devices across complex international markets

Job Summary

  • This role enables global market access for innovative hardware and software medical devices across complex international markets.
  • The successful candidate will translate evolving regulatory requirements like EU MDR into actionable plans while partnering with cross-functional teams.
  • Butterfly Network offers a hybrid work model, unlimited paid time off, comprehensive health insurance, and equity opportunities to all employees.

Matching Summary

This role enables global market access for innovative hardware and software medical devices across complex international markets.

Salary

Competitive salaried compensation; Equity provided; Not specified

Skills & Requirements

Must-have

  • 5+ years medical device regulatory experience
  • EU MDR 2017/745 knowledge
  • International submission management APAC MEA LATAM
  • Software in Medical Device SiMD expertise
  • ISO 13485 ISO 14971 IEC 62304 standards

Nice-to-have

  • Artificial Intelligence Machine Learning background
  • Regulatory Affairs Certification RAC
  • Cross-functional collaboration skills
  • Proactive problem-solving mindset
  • Fast-paced startup environment adaptability

Key Requirements

  • Bachelor's degree in scientific or engineering discipline
  • Minimum 5 years progressive regulatory affairs experience
  • Experience with Class II or higher medical devices
  • Hands-on experience with MDSAP countries and global regions
  • Proficiency in Quality Management System (QMS) processes

Work Rights

Not specified

Tailored Resume

Cover Letter