Quality and Regulatory Affairs Lead

  • Guilford, CT, USA
  • Full-time

Company Description

Butterfly Network is reinventing medical imaging and championing a new era of healthcare by creating the first ever pocket-sized, whole-body ultrasound device - the Butterfly iQ. This breakthrough technology has reduced the cost of the traditional ultrasound system by miniaturizing it onto a single semiconductor silicon chip. Our mission is to democratize healthcare by making medical imaging accessible to everyone around the world.

Since inception, Butterfly has raised over $375 million. The iQ is FDA-cleared and is being sold in hospitals and clinics around the globe.

Joining Butterfly Network is the opportunity to redesign the future of healthcare through the power of technology. Embark on a journey with us to maximize global impact, motivated by the idea that our products will change the lives of millions along with the people you love. 

Job Description

Quality and Regulatory Affairs Lead coordinates all activities involving development, implementation and maintenance of quality management systems and compliance across the company.

As part of our team, your core responsibilities will be: 

  • Establishing and maintaining the quality management system and ensuring quality standards are upheld across the organization
  • Establishing and maintaining key processes, procedures and documentation to support regulatory requirements and filings
  • Ensures internal and external compliance with stated practices and procedures 
  • Support regulatory and agency inspections and/or audits as necessary
  • Lead, support, and participate in auditing activities and regulatory inspections; evaluate responses to audit findings for adequacy and assurance of risk management

Qualifications

Baseline skills/experiences/attributes:

  • 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
  • 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
  • Track record of successfully working with and managing third-party vendors
  • Excellent documentation and dashboarding skills
  • Knowledge of paper and electronic QMS system
  • Knowledge of Regulatory Filings: In person knowledge of 510(k), De Novo, PMA, and international CE, C-FDA regulatory filing procedures

Ideally, you also have these skills/experiences/attributes (but it’s ok if you don’t!):

  • Experience in medical imaging strongly preferred

Additional Information

We offer great perks: 

  • Fully covered medical insurance plan, and dental & vision coverage - as a health-tech company, we place great worth on our teams’ well-being
  • Competitive salaried compensation - we value our employees and show it 
  • Equity - we want every employee to be a stakeholder
  • Pre-tax commuter benefits - we make your commute more reasonable 
  • Free onsite meals + kitchen stocked with snacks.
  • 401k plan - we facilitate your retirement goals
  • Beautiful office near the ocean-front in historic Guilford, Connecticut 
  • The opportunity to build a revolutionary healthcare product and save millions of lives! 

For this role, we provide visa assistance for qualified candidates. 

Butterfly network does not accept agency resumes.

Butterfly Network Inc. is an E-Verify Company and is an equal opportunity employer regardless of race, color, ancestry, religion, gender, national origin, sexual orientation, age, citizenship, marital status, disability or Veteran status. All your information will be kept confidential according to EEO guidelines.