Nadia Cheraiti

With more than 20 years experience in clinical trials and medical device regulation and a particular interest for innovative technologies, With high skills in regulatory and clinical expertise, I help medical device manufacturers companies worldwide, develop their clinical program.

I hold a PhD in bio organic Chemistry (Paris-Sud) and published extensively in scientific journals. I started my career in large pharmaceutical companies like Pfizer, Sanofi-Aventis and worked as Director of Regulatory Affairs and Clinical Operations in large CROs.

Hence overseeing all clinical investigation operations across EU countries, worked as VP of clinical and regulatory affairs in Medical device company, distributing and performing clinical studies and marketing registrations worldwide. I finally decided to work as freelance. I could further help manufacturers gain access to the European market to grow, innovate and further develop new medical technologies.

• 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.