Holti Kellezi

Holti Kellezi has a diverse work experience spanning multiple industries and roles. Holti is currently working at Dawn Health as the VP of Business Development & Digital Therapeutics. Holti previously held positions at Novo Nordisk as a Regulatory Affairs Professional and in the R&D Regulatory Affairs Graduate Program. Additionally, they founded and chaired Synapse - Life Science Connect and co-founded ClickFlow Medtech. Holti also worked as a Scientific Research Assistant at the Novo Nordisk Foundation Center for Basic Metabolic Research. Prior to that, Holti was the University Coordinator for the Danish Society of Engineers and served as a researcher and project manager for the iGEM Competition. Holti has had various other experiences in different organizations.

Holti Kellezi's education history is as follows:

- From 2009 to 2015, Holti attended Københavns Universitet - University of Copenhagen, where they obtained a Master of Science degree in Molecular Biomedicine.

- In 2015, they participated in the EIT Summer School at IESE Business School and received a Certificate of Completion in Entrepreneurship/Entrepreneurial Studies.

- In 2013, Holti attended Harvard University, specializing in Stem Cell and Regenerative Biology.

- In 2012, they participated in a Study Abroad Program at The University of Auckland, focusing on Biomedical Sciences.

- Holti also had professional education and attended various courses and certifications in Business Development & Regulatory Affairs.

In addition to their education, Holti Kellezi has obtained several certifications, including:

- Introduction to Usability Engineering and IEC 62366-1 from Medical Device HQ in April 2022.

- Clinical Evaluation for Medical Devices from BSI in February 2022.

- IEC 62304 - Medical Device Software - Software Lifecycle Processes from Prevas A/S in November 2020.

- Introduction to Risk Management for Medical Devices & ISO14971:2019 from Medical Device HQ in August 2020.

- Drug / Device Combination Products in EU & US from Novo Nordisk in October 2018.

- Medical Device - Drug/Device Combination Products from Atrium Copenhagen in October 2018.

- Understanding Digital Health and Electronic Products from The Organisation for Professionals in Regulatory Affairs – TOPRA in September 2018.

- Software Design for Medical Devices Global Conference 2018 from IQPC in February 2018.

- Medical Apps for Smartphones and Tablets from Medicoindustrien in November 2017.

- Overview of FDA Regulatory Compliance for Medical Devices Class from The Center for Professional Innovation & Education (CfPIE) in November 2017.

- Medical Devices: EU Directives, Guidance, CE Marking and ISO Standard Certifications from The Center for Professional Innovation & Education (CfPIE) in October 2017.

- ISO 13485:2016 Training for Internal Auditor from DNV GL Presafe AS in September 2017.

- Medical Device Software and Applications from Medical Device Training Company in September 2017.

- Healthcare Market Place (University of Minnesota, Coursera) from Coursera in March 2017.

- Managing the Project from Novo Nordisk in October 2015.

- Regulatory Life Cycle Management from Pharmakon in October 2015.

- Synapse BioBusiness Summer School from Synapse - Life Science Connect in August 2015.

- Doing Business In China from Doing Business In by Novozymes, The Boston Consulting Group, and Djoef in April 2015.