Elena Lucano

Elena Lucano, PhD, is a dynamic Regulatory Affairs and Quality Assurance consultant with a proven track record of leadership and collaboration in medical devices and digital health. Adept at managing projects from startups to big corporates and spearheading high-impact initiatives across the EU, US, Switzerland, and UK, ensuring alignment with rigorous regulatory frameworks and industry standards. Her engineering background gives her a robust foundation and understanding of the operation of medical devices, as well as aspects connected to their development and production. Over the years, she also got experience and insights on the aspect linked to the privacy of personal data, supporting with GDPR and HIPAA compliance activities. Elena takes over responsibilities and has a global approach when it comes to support customers. Sharp and methodical, she will structure and deliver services that will match customers’ expectations and policy. Elena is fluent in Italian, English and French and English.