Aslıhan Kara

Aslıhan Kara Email and Phone Number

MDR Clinical Specialist | Biologist | CER Writer @ Cantek Group
Aslıhan Kara's Location
Antalya, Türkiye, Turkey
Aslıhan Kara's Contact Details

Aslıhan Kara work email

Aslıhan Kara personal email

n/a
About Aslıhan Kara

Demonstrated experience in development of clinical data generation strategies, clinical study and survey design, study site selection and GCP compliance of clinical trials, Ethical Commitee and Ministry of Health submissions and relations, medical device clinical evaluation (MEDDEV 2.7.1 Rev 4), PMCF, PMS, MDR

Aslıhan Kara's Current Company Details
Cantek Group

Cantek Group

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MDR Clinical Specialist | Biologist | CER Writer
Website:
cantekgroup.com
Employees:
106
Aslıhan Kara Work Experience Details
  • Cantek Group
    Quality Assurance Manager At Semical Biosurgery
    Cantek Group Nov 2024 - Present
    Antalya, Türkiye
  • Cantek Group
    Clinical Affairs Specialist At Semical Biosurgery
    Cantek Group Jun 2023 - Present
    Antalya, Türkiye
  • Era Yönetim Test Ve Belgelendirme Hiz. A.Ş.
    Medical Device Clinical Project Manager And Clinical Team Lead
    Era Yönetim Test Ve Belgelendirme Hiz. A.Ş. Sep 2017 - May 2023
    Antalya, Türkiye
    Clinical evaluation of medical devices acc. to the MEDDEV 2.7/1 Rev.4Clinical project writing and management CEP, CER, SSCP, PMS-P, PMS-R, PSUR, PMCF-P, PMCF-R
  • Freelance
    Quality Management Consultant And Clinical Evaluation Specialist
    Freelance Nov 2015 - Sep 2017
    Adıyaman, Türkiye
    Quality Management System set up accordingly ISO 13485, GMP and local regulations, CE marking files of medical devices, clinical evaluation reports, post marketing surveillance plans.
  • Freelance
    Freelance Medical Translator
    Freelance Jan 2015 - Sep 2017
    Adiyaman, Turkey
    Translation to Turkish of regulatory and clinical study documents, medical sources and other medical documents.
  • Hacettepe University
    Clinical Research Coordinator
    Hacettepe University Jun 2009 - Dec 2014
    2013-2014 Altis CRO , Research Associate (Roche)2011-2012 EBM Research , Research Coordinator (GlaxoSmithKline)2008-2011 CRM-CRO, Research Coordinator (Novartis AG)Clinical research management in oncology, hematology, paediatric neurology with various sponsors (Novartis, GSK, Roche etc.)
  • Cimedis Pharmaceuticals
    Regulatory Affairs Specialist
    Cimedis Pharmaceuticals 2008 - 2009
    CE , ISO 9001 and 13485, GMP procedures, quality and efficacy analysis of disinfectant products
  • Orfoz Health
    Quality Assurance And Regulatory Specialist
    Orfoz Health 2005 - 2008
    GMP, ISO 9001 and ISO 13485 compliance of production, quality control for in vitro diagnostic products, CE marking of medical devices, CTD submission, validation, microbiological culture media production and R&D.

Aslıhan Kara Skills

Cancer Research Quality Management Clinical Trials Ich Gcp Gene Therapy Gmp Clinical Research Active Implantable Medical Devices Regulatory Affairs Translation Life Sciences 93/42/mdd Validation 90/385/mdd Medical Devices Quality Assurance Iso 9001 Targeted Therapies Pharmacovigilance Lifesciences Risk Analysis Medicine Clinical Monitoring Oncology Gcp Microbiology Cancer Pharmacology Breast Cancer Pharmaceutical Industry Iso 13485

Aslıhan Kara Education Details

Frequently Asked Questions about Aslıhan Kara

What company does Aslıhan Kara work for?

Aslıhan Kara works for Cantek Group

What is Aslıhan Kara's role at the current company?

Aslıhan Kara's current role is MDR Clinical Specialist | Biologist | CER Writer.

What is Aslıhan Kara's email address?

Aslıhan Kara's email address is as****@****oup.com

What schools did Aslıhan Kara attend?

Aslıhan Kara attended Anadolu Üniversitesi, Gazi Üniversitesi, Eskişehir Osmangazi Üniversitesi.

What skills is Aslıhan Kara known for?

Aslıhan Kara has skills like Cancer Research, Quality Management, Clinical Trials, Ich Gcp, Gene Therapy, Gmp, Clinical Research, Active Implantable Medical Devices, Regulatory Affairs, Translation, Life Sciences, 93/42/mdd.

Who are Aslıhan Kara's colleagues?

Aslıhan Kara's colleagues are Seher Mert, İsmail Okay, Hilal Caner, Çağrı Mudul, Hazal Dincer, Akın Can Aksoy, Ülküm Sultan Yazici.

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