Quality and Regulatory Affairs Lead

  • Guilford, CT, USA
  • Full-time

Company Description

Butterfly Network has created and brought to market the Butterfly IQ – the first FDA-cleared, portable device that puts ultrasound technology on a semiconductor chip. Pairing ultrasound-on-a-chip with the cloud and AI, we are doing something never done before, and bringing ultrasound to new domains around the world. Since inception, Butterfly has raised over $375 million. As we scale our team, we are seeking the best and the brightest engineers, across both the software and hardware worlds.

Job Description

Quality and Regulatory Affairs Lead coordinates all activities involving development, implementation and maintenance of quality management systems and compliance across the company. This position is ultimately responsible for establishing and maintaining the quality management system and ensuring quality standards are upheld across the organization, as well as establishing and maintaining key processes, procedures and documentation to support regulatory requirements and filings. Ensures internal and external compliance with stated practices and procedures and support regulatory and agency inspections and/or audits as necessary.

Qualifications

  • Minimum 7 years in a QA leadership role within the medical device industry with knowledge in GMP and GCP experience
  • Bachelor of Science or higher degree in a technical discipline
  • Experience in medical imaging strongly preferred
  • Hands-on leadership approach, experience managing and developing QARA team
  • Excellent documentation and dashboarding skills
  • Demonstrated experience in QA oversight and management of products through the lifecycle of medical device product development;
  •  Experienced QA leadership background with a track record of establishing and maintaining quality systems, practices and policies in the device development environment;
  • Deep experience with establishing and maintaining ISO, CFR, GxP, and other relevant compliant quality management systems across the device spectrum;
  • Experience applying GxP Quality knowledge through standard operating procedures (SOPs) to facilitate business operations and when needed develop procedural solutions to resolve quality and compliance challenges.
  • Experience applying Quality Systems (e.g., change control, deviations, CAPA, complaint management, and documentation management among others)
  • Thorough knowledge of FDA assessments of QSR processes;
  • Lead, support, and participate in auditing activities and regulatory inspections; evaluate responses to audit findings for adequacy and assurance of risk management
  • Track record of successfully working with and managing third-party vendors;
  • Excellent documentation and dashboarding skills

Typical Tools, Technologies

  • Paper and electronic QMS system
  • Regulatory Filings: In person knowledge of 510(k), De Novo, PMA, and international CE, C-FDA regulatory filing procedures

Additional Information

In addition to working with colleagues and advisors who are the best and brightest in their fields, building a revolutionary product and helping to save lives, we offer great perks:

  • Fully funded medical insurance, dental and vision coverage
  • 401K plan
  • Competitive salary and equity in the company
  • Free on-site meals, unlimited healthy snacks
  • Beautiful office near the waterfront in historic Guilford, CT
  • Pre-tax commuter benefits

Butterfly Network is an equal opportunity employer regardless of race, color, ancestry, religion, gender, national origin, sexual orientation, age, citizenship, marital status, disability, or Veteran status.