Regulatory Compliance Manager

Company Description

Butterfly Network's mission is to democratize healthcare by enabling universal access to superior medical imaging. We reinvented ultrasound technology by creating the world's first handheld, single-probe whole-body ultrasound system: the Butterfly iQ. This innovative technology reduces the cost of the traditional ultrasound system by miniaturizing it onto a single semiconductor silicon chip.

Butterfly harnesses the advantages of AI and cloud computing to deliver advanced imaging that is easy-to-use and built for the digital era. The Butterfly iQ and next-generation Butterfly iQ have received CE Mark and FDA clearance, and are 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

The Regulatory Compliance Manager will report into Post Market Quality and have the opportunity to build and maintain the regulatory compliance program including, but limited to, internal audits, post market reporting, health hazard evaluations, recalls, coordination and management of audit readiness, supporting global expansion and maintaining external standards/regulations. The Regulatory Compliance Manager will work closely with Quality, Regulatory Affairs and cross functional teams to ensure compliance with regulations. This individual will start as a process manager and build a team to scale with the organization.

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

Managing the regulatory compliance program, including:

• Ensure the organization maintains up-to-date policies and procedures, and operations are conducted in accordance with applicable International, Federal and State regulations
• Identify and prioritize internal risks and ensure issues are addressed
• Participate as an active member of the Quality Review Board
• Support the international expansion program ensuring country-specific QMS and post market regulatory requirements are identified and addressed with support from distribution partners and authorized representatives.
• Develop and Manage internal audit program and ensure internal audits are performed in accordance with procedures and other applicable external requirements
• Assist Quality with external audit/inspection preparation and inspection activities performed by regulatory agencies and business partners
• Lead the reporting of adverse events, reportable malfunctions, and corrections/removals/advisory notices for Butterfly Network products. Responsible for all correspondence between Butterfly Network, Inc. and the regulatory agencies relating to the reports filed.
• Participate on Project teams as required and work collaboratively with Quality, Regulatory Affairs, Legal, Compliance, Product, Operations and R&D departments to address gaps or implement process improvements
• Manage the assessment process for new or revised external standards/regulations for applicability to the Quality Management System (QMS) including maintaining the list and library of External Standards/Regulations
• May be expected to perform other duties as necessary which requiring similar skills or competency

Qualifications

Baseline skills/experiences/attributes:

• BA/BS degree in business, engineering, medical or scientific discipline.
• Related Experience: Minimum 5 years of regulatory compliance or quality auditing experience in the medical device industry commensurate with accountabilities described above. Minimum of 5 years experience working with regulatory agencies, Competent Authorities and Notified Bodies in a Medical Device company.
• Extensive knowledge and understanding of applicable US, European and International Medical Device Regulations, Standards and Guidance Documents including but not limited to current ISO 13485, CMDR SOR/98-282, transition from MDD 93/42/EEC to MDR 2017/745, 21 CFR Part 820, MDSAP, UK CA, and Australian medical device regulations and guidances.
• Experience maintaining and coordinating recall/market action
• Experience managing Internal Audits
• Experience operating on cross-functional teams for complex projects

Special Competencies or Certifications

• Certified Quality Auditor (CQA) preferred
• Regulatory Affairs Certification (RAC) or ASQ Auditor Certification a plus
• Experience with SaMD a plus
• Excellent oral and technical writing skills with the ability to interface effectively and professionally at all levels
• Demonstrated leadership and organization skills

You Deeply Identify with Core Butterfly Network Values:

• Efficient & Speedy - you get work done in a fraction of the time as industry peers
• Intellectually Curious - you are thoughtful & inquisitive; people enjoy working with you because they learn from you
• Mission-Driven & Committed - you are passionate about the company's purpose and are immensely productive
• Team Oriented - you celebrate and take joy in the success of others on the team

Additional Information

We offer great perks:

• Fully covered medical insurance plan (with dental & vision) - as a health-tech company, we place great worth on our teams' well-being
• 401k plan and match - we facilitate your retirement goals
• Work from Home - we offer a hybrid work environment, part time in the office and part time work from home
• Pre-tax commuter benefits - we make your commute more reasonable
• Unlimited Paid Time Off 15 Holiday Days a Year - recharge and come back ready to make an impact
• Parental Leave - for eligible employees, we provide a generous 10-week parental leave and additional 6-8 weeks pregnancy-related leave for birthing parents.
• Competitive salaried compensation - we value our employees and show it
• Equity - we want every employee to be a stakeholder

• Beautiful office overlooking the Flatiron building in NYC
• Kitchen stocked with snacks and beverages
• The opportunity to build a revolutionary healthcare product and save millions of lives!

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.

Butterfly Network requires, as a condition of employment, proof of vaccination for COVID-19 subject to accommodation for sincerely held religious beliefs and/or disability.