Dina Lakayan
Founder and Owner at CREATE Regulatory Affairs consultancy- Claim this Profile
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English Full professional proficiency
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Persian Native or bilingual proficiency
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Turkish Full professional proficiency
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Swedish Elementary proficiency
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Dutch Limited working proficiency
Topline Score
Bio
Valérie Dubois
I had the opportunity and the privilege to work with Dina during 6 months. I have been impressed by her speed of on boarding in the project and by her knowledge in the MD regulations, and most important, her interpretation. Pointing the regulatory issues, drawing clear table of pros and cons to make decisions. Furthermore Dina is always happy to share her knowledge, to educate the teams. She is definitely a great teammate!
John Murphy
Dina is a true professional with a solid understanding of regulations, regulatory bodies and quality systems, is a true team player and joy to work with. Her mastery of these topics and her can-do spirit afford her latitude and creativity when overcoming issues, finding solutions to difficult problems and making major contributions to the success of the organization. I highly recommend Dina if you are looking for leadership and support in your regulatory affairs endeavors.
Valérie Dubois
I had the opportunity and the privilege to work with Dina during 6 months. I have been impressed by her speed of on boarding in the project and by her knowledge in the MD regulations, and most important, her interpretation. Pointing the regulatory issues, drawing clear table of pros and cons to make decisions. Furthermore Dina is always happy to share her knowledge, to educate the teams. She is definitely a great teammate!
John Murphy
Dina is a true professional with a solid understanding of regulations, regulatory bodies and quality systems, is a true team player and joy to work with. Her mastery of these topics and her can-do spirit afford her latitude and creativity when overcoming issues, finding solutions to difficult problems and making major contributions to the success of the organization. I highly recommend Dina if you are looking for leadership and support in your regulatory affairs endeavors.
Valérie Dubois
I had the opportunity and the privilege to work with Dina during 6 months. I have been impressed by her speed of on boarding in the project and by her knowledge in the MD regulations, and most important, her interpretation. Pointing the regulatory issues, drawing clear table of pros and cons to make decisions. Furthermore Dina is always happy to share her knowledge, to educate the teams. She is definitely a great teammate!
John Murphy
Dina is a true professional with a solid understanding of regulations, regulatory bodies and quality systems, is a true team player and joy to work with. Her mastery of these topics and her can-do spirit afford her latitude and creativity when overcoming issues, finding solutions to difficult problems and making major contributions to the success of the organization. I highly recommend Dina if you are looking for leadership and support in your regulatory affairs endeavors.
Valérie Dubois
I had the opportunity and the privilege to work with Dina during 6 months. I have been impressed by her speed of on boarding in the project and by her knowledge in the MD regulations, and most important, her interpretation. Pointing the regulatory issues, drawing clear table of pros and cons to make decisions. Furthermore Dina is always happy to share her knowledge, to educate the teams. She is definitely a great teammate!
John Murphy
Dina is a true professional with a solid understanding of regulations, regulatory bodies and quality systems, is a true team player and joy to work with. Her mastery of these topics and her can-do spirit afford her latitude and creativity when overcoming issues, finding solutions to difficult problems and making major contributions to the success of the organization. I highly recommend Dina if you are looking for leadership and support in your regulatory affairs endeavors.
Experience
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CREATE Regulatory Affairs consultancy
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Netherlands
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Medical Equipment Manufacturing
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1 - 100 Employee
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Founder and Owner
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Oct 2020 - Present
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Santen
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Japan
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Pharmaceutical Manufacturing
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700 & Above Employee
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Senior Specialist, Medical Device Regulatory Affairs (Global)
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Apr 2020 - Oct 2020
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Elekta
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Sweden
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Medical Equipment Manufacturing
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700 & Above Employee
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Regulatory Affairs Engineer
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Dec 2018 - Apr 2020
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Regulatory Affairs Specialist
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Nov 2018 - Apr 2020
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Amaris
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Israel
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Design Services
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1 - 100 Employee
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Regulatory Affairs Consultant
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Oct 2016 - Oct 2018
Amaris is specialised in RA&QA in the field of Medical Devices, ISO 13485, ISO 9001, ISO 14791, ISO 10993 and Medical Device Directive and Regulations. My responsibilities at Amaris is working on the technical file documentation, clinical and biological evaluation reports, design dossiers, risk assessment files, revision of IFUs and labelling and adoption for the changes from MDD toward MDR. Amaris is specialised in RA&QA in the field of Medical Devices, ISO 13485, ISO 9001, ISO 14791, ISO 10993 and Medical Device Directive and Regulations. My responsibilities at Amaris is working on the technical file documentation, clinical and biological evaluation reports, design dossiers, risk assessment files, revision of IFUs and labelling and adoption for the changes from MDD toward MDR.
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Vrije Universiteit Amsterdam (VU Amsterdam)
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Netherlands
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Higher Education
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700 & Above Employee
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Ph.D. Candidate
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Oct 2012 - Sep 2016
Surface Plasmon Resonance (SPR)-coupled liquid chromatography-surface plasmon resonance biosensing.HPLC (Reverse phase chromatography, size exclusion chromatography, ion exchange chromatography). Routine analysis with CE, MS, MS/MS and GC. Supervison of liquid chromatography practical courses, from method development till validation.
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Lab assistance
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Sep 2012 - Jan 2016
System buildup and method development using liquid chromatography
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Organization, hosting
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Oct 2014 - Oct 2014
MP-SPR TRAINING AND SCIENTIFIC MEETING EUROPE, BioNavis Ltd.
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Lecturer
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Aug 2016 - Aug 2016
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Synthon pharmaceuticals
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United States
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Individual and Family Services
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PhD secondment
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Dec 2015 - Jan 2016
Method development for quality assurance and safety of the new therapeutics, ADCs. Liquid chromatography (LC) separation, followed by SPR biointeraction detection. Mainly worked with size exclusion chromatography, ion exchange chromatography and validation procedures. Additionally, I have gained experience by working at a pharmaceutical industry laboratory, where I advanced my skills in GMP, GLP work environment. Method development for quality assurance and safety of the new therapeutics, ADCs. Liquid chromatography (LC) separation, followed by SPR biointeraction detection. Mainly worked with size exclusion chromatography, ion exchange chromatography and validation procedures. Additionally, I have gained experience by working at a pharmaceutical industry laboratory, where I advanced my skills in GMP, GLP work environment.
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BioNavis Oy
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Finland
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Biotechnology
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1 - 100 Employee
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Industrial collaboration
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Sep 2012 - Jan 2016
SPR hardware and software development. Multiwavelength and multiplex, Multiparametric SPR. SPR hardware and software development. Multiwavelength and multiplex, Multiparametric SPR.
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Stockholm University
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Sweden
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Research Services
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700 & Above Employee
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Master’s research project
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Mar 2012 - Sep 2012
Biological sample purification and LC-MS/MS
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Master’s practical training
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Feb 2012 - Mar 2012
Cell culturing and protein purification, PCR, SDS gel
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Master’s research project
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Sep 2011 - Feb 2012
Combinatorial Analysis of Time Series “CATS” is a program that is written in MATLAB. CATS special features makes it specific from other software.
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Summer Analyst
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Jun 2011 - Sep 2011
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Education
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2012 - 2016
Vrije Universiteit Amsterdam
Doctor of Philosophy (Ph.D.), Chemistry- BioMolecular analysis -
2010 - 2012
Stockholms universitet / Stockholm University
Master of Science (M.Sc.), Analytical Chemistry -
2006 - 2009
Ray Azad University-Tehran /Iran
Bachelor’s Degree, Applied Chemistry
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