Global Complaint Director
- 251 W 30th St, New York, NY 10001, USA
Butterfly Network’s mission is to democratize medical imaging, a life-saving technology that is inaccessible to the 2/3 of the world. We operate at the intersection of hardware, software, and medicine and have created the first affordable full stack solution to this problem. If you have a passion for doing challenging work that will touch the lives of those you love, you will enjoy working with us.
The Butterfly iQ is the world’s first handheld whole-body imager. Built upon first of its kind technology that miniaturizes the traditional ultrasound system onto a single semiconductor chip, iQ is combined with a natively mobile-first, cloud-based software platform and AI assistance. The iQ is FDA-cleared and will be shipping to doctors and hospitals this year. There has never been a more exciting time to join us in revolutionizing the medical imaging industry and saving the lives of people around the globe.
This role will be responsible for managing the Post Market Surveillance and all related compliance
activities associated with the complaint handling of the world’s first personal ultrasound device.
- Review information provided from multiple internal and external customer feedback systems and provide evaluation as to whether these service events constitute complaints.
- Ensure all complaints are reviewed, evaluated, and investigated to determine reportability to FDA and International Regulatory Authorities
- Ensure appropriate training is provided to the Customer Support staff
- Coordinate and participate in the escalation of adverse complaint trends or product issues
- Coordinate with team members in obtaining any missing information
- Document the complaint in appropriate systems
- Confirm complaint conditions and determine corrective action (including CAPA as needed)
- Collaborate with Development Engineers and Scientists, Clinical Specialists, and
- Manufacturing personnel to facilitate the complaint investigation process
- Review each complaint and determine eligibility for adverse event reporting to worldwide regulatory agencies.
- Analyze complaint data and trends share feedback to the development and manufacturing teams, suggest potential product improvements, product defects, and safety evaluations, and resolve complaints
- Oversee the accuracy, completeness, and maintenance of the complaint records
- Implement Global Complaint Management system.
- 10+ years’ of postmarket complaints experience in the Medical Device industry
- Bachelor’s degree in engineering, clinical sciences, related sciences, or equivalent experience
- Working knowledge of appropriate global medical device regulations, requirements, and standards such as ISO 13485 and 21 CFR Part 821 and 803
- Exceptional attention to detail and organization skills
- Excellent communication skills (written and verbal) for coordinating internally and with regulatory authorities worldwide
In addition to working with colleagues and advisors who are the best and brightest in their fields, we offer great perks:
- Fully funded medical insurance, dental, vision coverage
- 401K plan
- Competitive salary + equity
- Free on-site meals, unlimited healthy snacks
- Pre-tax commuter benefits
- Brand new office in the heart of Manhattan or an oceanfront office in historic Guilford, CT
- The chance to help improve the healthcare and save millions of lives!
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.
Butterfly Network does not accept agency resumes