Amina Sakly available

Amina Sakly

Regulatory and clinical Affairs specialist

available
Profileimage by Amina Sakly Regulatory and clinical Affairs specialist from
  • Freelancer in
  • Graduation: PHD in Biological Sciences and Biotechnologies
  • Hourly-/Daily rates: 3 €/hour 6 €/day
  • Languages: Arabic (Native or Bilingual) | English (Limited professional) | French (Native or Bilingual)
  • Last update: 23.08.2018
KEYWORDS
ATTACHMENTS
CV
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SKILLS
- Regulatory Affairs Manager
? Preparation and submission of required documentation for the registration of new medical devices in different countries (ASIA (China, Japan, Taiwan, MENA countries (including KSA, Morocco, etc…), Australia, USA (FDA - listing of class I devices), EUROPE etc….)
Curriculum Vitae
2
? Gather and assemble information necessary for submissions of medical devices in accordance with regulations and relevant guidelines.
? Studying countries’ Labelling, Vigilance, Recall and registration requirements and ensuring compliance with regulatory agencies’ regulations.
? Prepare responses to regulatory agencies questions and other correspondence.
? Follow up of legalization issues with governments and consular services (In Liechtenstein and Switzerland) for several countries.
- Research and Development Manager
? Contribution in the development of new products according to the ISO 13485 requirements (Development of a medical device class I for the treatment of ulcer)
? Generating SOP for design and development according to section 7.3 of the ISO 13485:2016 and follow up of other projects.
- Clinical affairs manager
? Participate and manage the overall day-to-day operations of multiple clinical studies.
? Follow up of preclinical studies (according to ISO 10993) and clinical studies (according to ISO 14155) with expert panels.
? Coordinate and prepare Clinical Investigational Plans and supporting clinical study materials.
? Creation of procedure for the establishment of Clinical evaluation report according to MEDDEV 2.7.1.
? Creation of clinical evaluation reports for all products and writing as well as submitting studies in international journals
- Member of the Quality Department
? Knowledge about the requirements of ISO 13485 for Quality Management System.
? Participation in internal audits and assisting in external audits for recertification in ISO9001 / ISO13485
? Conformity assessment of class I, IIa and IIb products according to Annex I of MDD
? Follow up of products’ technical files (Keep up to date)
? Risk management for medical devices according to EN ISO 14971: general overview and risk based thinking principles.
? Development of Vigilance Reporting procedure according to MEDDEV 2.12-1
? Follow up of new standards, perform a gap assessment and ensure compliance with their requirements
REFERENCES
- UNIVERSITY ASSISTANT (2009 > 2013)
? The Higher Institute of Biotechnology - Monastir Tunisia (2009 > 2010) (Structural Biochemistry and Metabolic Biochemistry).
? The Faculty of Pharmacy - Monastir Tunisia (2010 > 2013) (Human Physiology and Cellular Biology).
- Regulatory / Clinical affairs (2012 > present) Bonyf AG company in Liechtenstein. 
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