HANAN ALI
Mancini Way, Ottawa, ON. K*J*X* – ***
acu731@r.postjobfree.com ) 869-****-*** (
PROFILE
More than 10 years of experience in medical healthcare sector as physician with excellent people oriented skills
Experienced manager of projects, Training groups, staff and monitoring of resources with Ability to multi-tasking
Competent in performing risk identification and evaluation
Excellent Detail oriented, and data analysis
Excellent Organizational skills with knowledge in working in a highly regulated sector
Excellent communication, presentation skills.
Technical proficiency with Biotechnology laboratory procedures and equipment EXPERIENCE
Regulatory Affairs specialist Sept – Dec 2015
DNA Genotek Inc., Ottawa, Ontario
Performed post-market risk identification and evaluation of medical device complaints
Translated and reviewed translation of submission documents IFU, labels from English to Arabic and vice versa.
prepared documents for medical device submission to EMEA and Health Canada
Reviewed medical device labels, instructions for use and advertising materials
Completed Canada medical device and drug regulation training
Completed United States FDA medical device and drug classification and submission training
Completed European Union medical device, drug and IVD CE marking training
Completed medical device risk management training
Completed overview of ISO 13485 medical device quality system training
Gained proficiency in use of electronic document control management system Medical Doctor 2009 - 2013
Herra Medical Center, ENT specialist Riyadh, Saudi Arabia
Used latest technology in Ear, Nose and Throat Diagnostic unit to diagnose and treat patients
Monitored the processing of insurance claims for more than 500 patients monthly, complied and negotiated with insurance companies regarding insurance claims, payment and technical approval issues
Evaluated ISO 9000 regulation and provided reports and recommendations to improve and maintain the health and safety of company employees
Applied training to new medical staff regarding the audiological tests instruments Medical Liaison 2004 - 2009
Alshamail Medical center, Riyadh Saudi Arabia
Represented the medical center in Ministry of Health meetings
Monitored and tracked changes and updates of legislation in health sector
Analyzed, interpreted and applied regulations, Coordinated programs (continuing education& training programs),
Managed a medical clinic with 75 employees, working with multi-disciplinary and multi-ethnic teams
Approved and monitored clinic resources including inventory and equipment.
Excellent customer service experience responded to patient inquiry related to clinic services and insurance coverage
Skills
Gained Technical proficiency and experience in:
Completed Level II Biosafety lab, Occupational Health and Safety and WHMIS regulation/training
Familiar with GLP, GMP and GCP, ICH Guidelines, thorough understanding of standard operating procedures.
Good understanding of FDA and EU Directive regulations, EMEA, and local regulatory requirements with Great knowledge of pre-clinical and clinical compliance
Thorough understanding of clinical research principles and process.
Gene cloning (polymerase chain reaction (various PCR subtypes), restriction digestion, ligation, colony screening, DNA isolation and sequencing), specialty plasmid design and construction
identification of proteins using Sodium dodecyl sulfate polyacrylamide gel electrophoresis (SDS- PAGE and blotting), The enzyme-linked immunosorbent assay (ELISA)
Sampling and analysis by using high-performance liquid chromatography (HPLC), Mass spectrometer, GC –flam ionized detector (FID), Fourier transform infrared spectroscopy (FTIR).
Tissue culture work (preparation of culture media, passage of cells and maintenance of culture, calculation of in vitro cell age, Glucose concentration in tissues)
Gained Bio Ready certificate from Bio Talent Canada
Successful completion of TCPS-2 training
EDUCATION
Biotechnology- Advanced Program 2015
Algonquin College, Ottawa, Ontario
Bachelor of Medicine and general Surgery 1989
Medical School, Alexandria University, Egypt
Post Bachelor Diploma in ENT Disease 1994
Medical school, Almonofia Egypt
VOLUNTEERING 1992
Preventive Medicine, Maternal and Child care Counselor Ministry of Health Alexandria, Egypt
Counselor for Women, high risk group youth/young girls and child health care, family planning, contraceptive methods and sexually transmitted diseases
Developed and implemented/facilitated workshops which meet the identified needs of the participants
Participated in the development and implementation of special projects such as conference and training programs experience in group facilitation. Languages: English, Arabic and French
Computer Skills: Microsoft Office: Word, Excel and Outlook r service experience, Projects and maintains a