Nadia Cheraiti

• PhD in Bio-Inorganic Chemistry and BSc Chemical Engineer 
• 22 years clinical operations and regulatory affairs experience.
• 17 years Medical device experience with device class I – III experience (primarily cardiovascular and neurological devices, 
• 12 years Clinical Operations and Regulatory Affairs Director 
• 10 years CPM/Senior PM experience
• Extensive experience overseeing the MDD to MDR process and supervising all SOP changes
• Strong global management experience (35 people plus contractors)

Extensive vendor and budget management experience, including collaborations with big Groups

Director of Clinical & Regulatory Affairs

• Leading and coordinating the Clinical and Regulatory Affairs of the company
• Develop the Regulatory strategy for the development programs
• Responsible contact person for all the necessary interactions with the Regulatory Ø Authorities and for the declarations of materials vigilance
• Interacting with regulatory agencies; with external consultants or attorneys when needed to answer questions and obtain information
• Responsible for all the submitted regulatory documents.
• Supervising the medical and clinical evaluation process of the company’s medical devices
• Leading the development of the main elements of the scientific communication, articles and summaries, as well as other communications
• Management experience with the full range of business functions and systems including Clinical and Regulatory Affairs, strategic development and planning, budgeting, and Business development. 
• Establishment of a set of operating procedures covering all the Clinical Research activity and documentation for clinical regulatory
• Development of Management Tools (Forecast tables, tracking, filing tools, etc.)
• Document Management of study records.