Dilsat Pinar Pergjetani
Chief Quality & Regulatory Affairs Officer at Human Care Group- Claim this Profile
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English Full professional proficiency
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Turkish Native or bilingual proficiency
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Swedish Elementary proficiency
Topline Score
Bio
Tansel Mercan
Dilşat was one of the most proffessional and delicate people that i worked with. Her attentive and solution oriented manner always impressed me a lot
Victoria Clark
Dilsat wrote an article summarising the regulatory requirements for medical devices in Turkey for publication in the Journal of Medical Device Regulation. She is clearly knowledgeable in her subject area and writes in a clear, well structured way. She was able to meet the required deadlines and provide prompt feedback. She was a pleasure to work with.
Tansel Mercan
Dilşat was one of the most proffessional and delicate people that i worked with. Her attentive and solution oriented manner always impressed me a lot
Victoria Clark
Dilsat wrote an article summarising the regulatory requirements for medical devices in Turkey for publication in the Journal of Medical Device Regulation. She is clearly knowledgeable in her subject area and writes in a clear, well structured way. She was able to meet the required deadlines and provide prompt feedback. She was a pleasure to work with.
Tansel Mercan
Dilşat was one of the most proffessional and delicate people that i worked with. Her attentive and solution oriented manner always impressed me a lot
Victoria Clark
Dilsat wrote an article summarising the regulatory requirements for medical devices in Turkey for publication in the Journal of Medical Device Regulation. She is clearly knowledgeable in her subject area and writes in a clear, well structured way. She was able to meet the required deadlines and provide prompt feedback. She was a pleasure to work with.
Tansel Mercan
Dilşat was one of the most proffessional and delicate people that i worked with. Her attentive and solution oriented manner always impressed me a lot
Victoria Clark
Dilsat wrote an article summarising the regulatory requirements for medical devices in Turkey for publication in the Journal of Medical Device Regulation. She is clearly knowledgeable in her subject area and writes in a clear, well structured way. She was able to meet the required deadlines and provide prompt feedback. She was a pleasure to work with.
Credentials
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Auditing to EU MDR
PhilipsFeb, 2019- Nov, 2024 -
Corrective and Preventive Action (CAPA) Training
US FDA Danışmanlık ve Eğitim/US FDA Consulting and TrainingFeb, 2013- Nov, 2024 -
The US FDA Quality System Regulations (21 CFR 820)
US FDA Danışmanlık ve Eğitim/US FDA Consulting and TrainingFeb, 2013- Nov, 2024 -
Medical Device Legislation and TITUBB (National Health Database) Training
Duzey Group TrainingFeb, 2012- Nov, 2024 -
Auditing ISO 13485 & 9001 Quality Systems with focus on marketing and sales processes
MIKROCENTRUMJan, 2012- Nov, 2024 -
Medical Device and In-Vitro Medical Device Directives Training
TSE - Turkish Standards InstitutionDec, 2011- Nov, 2024 -
Regulatory Compliance, Post Market Surveillance and The Council Directive MDD 93/42 EEC Training
KalitestSep, 2011- Nov, 2024
Experience
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Human Care Group
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Hospitals and Health Care
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1 - 100 Employee
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Chief Quality & Regulatory Affairs Officer
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Feb 2022 - Present
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Education
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2004 - 2008
Istanbul University
Bachelor's degree, Microbiology, General
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