
Renat Biktimerov
Doctor Intern

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About me
Auditor by Healthcare/Chemicals products manufacturing of QSMS.Technical expert by ISO 15189:2012/ISO 13485:2017
Education

Pirogov Russian National Research Medical University (RNRMU)
2005 - 2008PhD Student of Clinical Laboratory Diagnostics Specialist in Clinical Laboratory DiagnosticsActivities and Societies: Society of post-graduate students and young scientists. Junior Researcher. Applicant at the Department of Clinical Laboratory Diagnostics of the Russian State Medical University (specialty "Clinical Laboratory Diagnostics").

Frumkin Institute of Physical chemistry and Electrochemistry Russian academy of sciences (IPCE RAS)
2004 - 2007PhD Student o Chromatography and Chromatographic Devices Chromatography and Chromatographic DevicesActivities and Societies: 1. Participation in International Congresses and Conferences with poster presentations. 2. Society of graduate students and young scientists The study of the theory of sorption and desorption, the fundamentals of physical chemistry in the field of biomedicine, analytical and preparative chromatography. Internships in Russia at leading institutes of the Russian Academy of Sciences. Work with Medical Devices, including sorbents and nanomaterials, micromechanics, optics. Installed Chromatographic Devices used as Medical Devices in Russia.

Chita State Medical Academy of the Ministry of Health of the Russian Federation
2000 - 2001Intern Doctor Doctor of Clinical Laboratory DiagnosticsActivities and Societies: Regional Society of Physicians for Clinical Laboratory Diagnostics Participation in the work of the regional Society of Specialists in Clinical Laboratory Diagnostics: Seminars, Trainings, Teleconferences.

Chita State Medical Academy of the Ministry of Health of the Russian Federation
1994 - 2000Doctor specialist Medical Care 4,85Activities and Societies: 1. Student Scientific Society on Neurology. 2. Participation in annual scientific student Conferences, Seminars. Classic higher medical education. Therapeutic and prophylactic faculty.
Experience

Regional Clinical Hospital, Chita, Russia
Jul 2000 - Jul 2001Doctor InternJob Description and Skills: Theoretical and practical knowledge in all sections of laboratory medicine: clinical chemistry, immunochemistry (immunology), hematology, hemostasis, immunohematology, microbiology, infectious immunology, histology, cytology, genetic research, clinical pharmacokinetics. Compliance with the Laws of professional Ethics and Deontology.

Chita Regional Medical Diagnostic Center /Department of Clinical Chemistry, Russia
Jul 2001 - Sept 2004Doctor of Clinical Laboratory Diagnostics, Laboratory of Clinical PharmacokineticsJob Description and Skills: Practical experience of technical audit, adaptation of reagents in the field of application of Medical devices in the laboratory medicine section - clinical pharmacokinetics, biomedical chromatography. Therapeutic drug monitoring: anticonvulsants - phenobarbital, finlepsin, depakin, diphenin, ethosuximide, β-blockers non-selective - propranolol, selective - atenolol, metoprolol, talinolol and other groups of drugs; Quality control of laboratory tests. Compliance with the Laws of professional Ethics and Deontology. Show less

Moscow Regional Drug-Abuse Health-Center, Russia
Oct 2004 - Jan 2008Doctor by specialty Clinical Laboratory Diagnostics / Department of Chemical Toxicology LaboratoryJob Description and Skills: Audits of First Party in ISO 9001: 2000 (Internal) for Department of Chemical Toxicology Laboratory of Moscow Regional Drug-Abuse Health-Center. Urine screening for the presence of narcotic substances and their metabolites (morphine, methamphetamine, cocaine, marijuana); Quality control of laboratory tests. Compliance with the Laws of professional Ethics and Deontology

All-Russian Scientific Research Institute of the Meat Industry, V.M. Gorbatov RAAS, Russia
Feb 2008 - Sept 2010Researcher / Department of Scientific-Methodical and Control and Analytical StudiesJob Description and Skills: Development and adaptation of analysis techniques in the food industry, translation of manuals for laboratory equipment, writing articles, GOSTs, MUKs, MVI, holding seminars and employee training.Works in the field of amino acid analysis (classical analysis with post-column derivatization with ninhydrin), ion chromatography - fluorides, chlorides, nitrates, nitrites, sulfates, phosphates, liquid chromatography - antibiotics, antioxidants, dietary supplements, water-and fat-soluble vitamins, benzopyrene, food additives, gas chromatography with mass spectrometric detection - fatty acids, pesticides, aromatic additives. Work in the meat industry is meat and meat-containing products, canned food, sports nutrition, work is somehow connected with nanomaterials, sorbents, micromechanics and optics.Compliance with the Laws of professional Ethics and Deontology. Show less

"Bioanalyt" LLC
Oct 2010 - Apr 2011Manager / Department of Chromatography and Mass SpectrometryJob Description and Skills: Audits of First Party in ISO 9001: 2008 (Internal). B2B sales - Establishing and developing new contacts, as well as maintaining existing business relationships with customers; Participation in tender procedures; The conclusion and support of contracts for the supply of equipment; Business trips across Russia and the World for the purpose of product promotion and negotiations; Professional advice to customers on the company's products and services; Identification of customer needs in the products sold by the company, and coordination of orders with the customer in accordance with its needs; Reporting on sales and shipments to customers; Technical, Service, Pre-Sales Consultations for Customers - in the field of Medical Devices, Food, Chemical Industry, Atomic Energy. Practical experience of technical audit, adaptation of reagents in the field of application of Medical Devices in the laboratory medicine section - clinical pharmacokinetics, biomedical chromatography. Compliance with the Laws of professional Ethics and Deontology. Show less

"KDL Domodedovo-Test" LLC
May 2011 - Sept 2011Doctor by specialty Clinical Laboratory Diagnostics / In vitro diagnostics (IVD) Production MoscowJob Description and Skills: Audits of First Party in ISO 9001: 2008 (Internal) for In vitro diagnostics (IVD) Production Moscow Gilyarovsky. Providing advice to doctors and patients regarding the choice of type of laboratory research and the use of services. Consultations regarding the repetition rate of laboratory tests and the required type of biosample. Review claims, complaints, and other referrals from clinicians, patients, or other parties. Compliance with the Laws of professional Ethics and Deontology. Show less

Transbaikal Territorial Oncology Center, Chita, Russia
Nov 2011 - May 2012Doctor by specialty Clinical Laboratory Diagnostics / Department of Clinical Laboratory DiagnosticsJob Description and Skills: Audits of First Party in ISO 9001: 2008 (Internal) for Department of Clinical Laboratory Diagnostics in Trans-Baikal Territorial Oncology Center. Biochemistry, Isoimmunology, Cytological examination of smears (scrapings) from the surface of the cervix (external uterine throat) and the cervical canal. Practical experience of technical audit, adaptation of reagents in the field of application of Medical Devices in the laboratory medicine section - Clinical Chemistry and Laboratory Medicine (CCLM). Compliance with the Laws of professional Ethics and Deontology Show less

"Irbis" LLC., Chita, Russia
Jun 2012 - Sept 2012Medical consultant / Department of Medical DevicesJob Description and Skills: Audits of First Party in ISO 9001: 2008 (Internal) for "Irbis" Ltd. Audits (Technical ) of Third-party for medical organizations, hospitals, medical laboratories. Adaptation of laboratory medical analysis techniques, Installation, User training on biochemical, hematological, coagulometric Medical Devices. Technical, Service, Pre-sale Consultations for doctors of Clinical Laboratory Diagnostics, Heads of Clinical Diagnostic Laboratories, Head Physicians. Practical experience of technical audit, adaptation of reagents in the field of application of Medical Devices in the laboratory medicine section - Clinical Chemistry and Laboratory Medicine (CCLM). Compliance with the Laws of professional Ethics and Deontology. Show less

"Rochen Medical Group" LLC., Moscow - St. Petersburg, Russia
Oct 2012 - Dec 2013Job Description and Skills: Audits (Technical) of Third-party medical organizations, hospitals, medical laboratories. Resolution of controversial issues and execution of necessary documentation (Certificates of Conformity, Registration Certificates, etc.) with state Regulatory and Surveillance authorities: the Russian Antimonopoly Authority in Moscow and the Territorial Districts of the Russian Federation (FAS and FAS regional office), the Federal Agency for Technical Regulation and Metrology (RosStandard) in Moscow, Federal Service for Surveillance in Health Care in Moscow (RosZdzdravNadzor).Organization of work and effective interaction of production units and structural units of the company. Development of a company development strategy. Tracking the execution of all orders of the CEO. Improving the system of motivation (reward) of employees of the company and its implementation. Observance of labor discipline, execution of orders and orders. Responsibility for the proper organization of office works in the company, legal and economic development of contracts, contracts, agreements, etc. Drawing up operational plans (monthly and decade) companies and approving them from the general director. Control over the activities of units to implement the approved plans. Identify and eliminate, independently and with management, deficiencies in the work of the company. Performance of separate official tasks and instructions of the General Manager. Compliance with the Laws of professional Ethics and Deontology. Show less Job Description and Skills: Audits of First Party in ISO 9001: 2008 (Internal) for "Rochen Medical Group" LLC Audits (Technical ) of Third-party for medical organizations, hospitals, medical laboratories. Adaptation of laboratory medical analysis techniques, Installation, User training on biochemical, hematological, coagulometric Medical Devices. Technical, Service, Pre-sale Consultations for Doctors of Clinical Laboratory Diagnostics, Heads of Clinical Diagnostic Laboratories, Head Physicians. Works on technical and service maintenance, installation and assembly of laboratory devices for medical purposes and logistics, as well as B2B and B2C sales.Compliance with the Laws of professional Ethics and Deontology. Show less
Transferred to the position of Executive Director / Moscow office
Jul 2013 - Dec 2013Medical consultant / Moscow office, Division of Medical Devices, Reagents and Medical consumables
Oct 2012 - Jul 2013

"Scientific Production Company" HELIX " LLC., Moscow - St. Petersburg, Russia
Dec 2013 - Jun 2014Doctor by specialty Clinical Laboratory Diagnostics / Department of Clinical Laboratory DiagnosticsJob Description and Skills: Biochemistry, Immunochemistry, Cytological examination of smears (scrapings) from the surface of the cervix (external uterine throat) and the cervical canal, Differential White Blood Cell Count, Complete Urinalysis, Quality control of laboratory tests. Practical experience of technical audit, adaptation of reagents in the field of application of Medical Devices in the laboratory medicine section - Clinical Chemistry and Laboratory Medicine (CCLM). Compliance with the Laws of professional Ethics and Deontology. Show less

"Helena RUS" LLC
Aug 2014 - Jan 2015Specialist in Technology and Production of Medical Devices (Application and Adaptolog)Job Description and Skills: Adaptation of reagents to coagulometric laboratory methods of medical analysis, Installation, Training Users to work on Medical Devices for Capillary Electrophoresis, Gel Electrophoresis, Coagulometers (automatic and semi-automatic) by Helena Biosciences Europe (United Kingdom). Development, Planning with the possibility of further Localization in Russia of Production (together with Chinese business partners) of innovative automatic Medical Devices for their use in the Federal Network Medical Laboratories of Russia. Audits (Technical) of Third Party at the Federal Network Medical Laboratories of Russia with the assessment of the Installability of the User of such innovative Medical Devices. Technical, Service, Pre-sale Consultations for Doctors of Clinical Laboratory Diagnostics, Heads of Clinical Diagnostic Laboratories, Head Physicians. Resolution of controversial issues and execution of necessary documentation (Certificates of Conformity, Registration Certificates, etc.) with state Regulatory and Surveillance authorities: the Russian Antimonopoly Authority in Moscow and the Territorial Districts of the Russian Federation (FAS and FAS regional office), the Federal Agency for Technical Regulation and Metrology (RosStandard) in Moscow, Federal Service for Surveillance in Health Care in Moscow (RosZdzdravNadzor). Compliance with the Laws of professional Ethics and Deontology. Show less

"Helena RUS" LLC
Jun 2015 - Jul 2015Development Transferred to the position of Quality ManagerJob Description and Skills: Development Transferred to the position of Quality Manager in Technical Support Department, and maintenance of the Quality Management System ISO 9001:2008. Performance of operational functions for quality assurance. Development of quality measures. Debugging of the Quality Control System. Maintenance and Quality Assurance. Audits of Third Party in ISO 9001: 2008 and Audits of First Party in ISO 9001: 2008 (Internal) for "Helena RUS" LLC. Audits (Technical) of Third-party for Medical Organizations, Hospitals, Medical Laboratories. Practical experience of the Technical audit in the field of application of Medical Devices in the sections of Laboratory Medicine and Clinical Chemistry (CCLM): Clinical capillary and gel electrophoresis, Hemostasis. (United Kingdom: Helena Biosciences Europe)Compliance with the Laws of professional Ethics and Deontology. Show less

"Astra-77" LLC
Dec 2015 - Dec 2016Head of Point of Care, Hemostasis and Urinary Chemistry in the Department of MarketingJob Description and Skills:Head of Point of Care, Hemostasis and Urinary Chemistry in the Department of MarketingStudy of the current market and market trends of Medical Devices - Point of caret, Urinary chemistry, Hemostasis. Study of the current needs of users on the basis of statistical analysis of sales of the assigned direction for the reporting period. Choosing a target market. Develop a competitive advantage. Approval of the sales development plan. Company sales management. User Relationship Management. Analysis of the identified discrepancies in the marketing policy of the entrusted direction, the application of targeted corrective and preventive actions, in accordance with the approved basic strategic marketing plan and sales policy.Audits (Technical) of Third-party medical organizations, hospitals, medical laboratories. Practical experience of the Technical audit in the field of application of Medical Devices in the sections of Laboratory Medicine and Clinical Chemistry (CCLM): Point of Care, Urinary Chemistry, Hemostasis (Germany: Siemens, Sysmex, Bio-Rad).Compliance with the Laws of professional Ethics and Deontology. Show less

"Renox" LLC
Jul 2016 - nowGeneral ManagerEducation: TUV NORD CERT GmbH / Essen, Germany and SERT Academy LLC, Moscow, RussiaCERT International, Bratislava, Slovak Republic and CERT Academy LLC, Moscow, RussiaAutonomous Non-Profit Organization of Higher Education "St. Petersburg Law Academy" and Center for Scientific and Technical Information Progress "Progress" LLC, St. Petersburg, RussiaJob Description and Skills:Audits of First Party in ISO 9001: 2000 (Internal)Audits of Third Party in ISO 9001: 2008 Audits of First Party in ISO 13485: 2012 (Internal)Audits (Technical ) of Third-party for medical organizations, hospitals, medical laboratoriesPractical experience of the Technical Audit of Laboratories with Medical Devices in the following sections of Clinical Chemistry and Laboratory Medicine: immunochemistry (immunology), hematology, hemostasis, immunomatology, microbiology, infectious immunology, histology, cytology, genetic research, Medical Devices for in vitro diagnostics, other than those listed above, Medical Devices, having in its composition human blood derivatives, Medical Devices using animal tissue: vaccines and serums. Practical experience of Technical Audit of Laboratories with Software for QC laboratory tests and software for automation and barcoding of streams in the four largest Russian laboratory networks: KDL-Test, Helix, Hemotest, Invitro, through the Russian distributor Siemens Health Care. Practical experience of technical audit of laboratories with Medical Devices with sorbents, nanomaterials, optics and micromechanics in HPLC.Practical experience of the Technical Audit of Hospitals with Medical Devices on Visualization Devices, Monitoring Devices, Active (Non-Implantable) Medical Devices: syringe pumps, infusomats, bedside monitors, fetal monitors.Calibration, Adaptation of reagents, Logistics, Service, B2B and B2C Sales in the field of Medical Devices. Compliance with the Laws of professional Ethics and Deontology. Show less

"Diacon" Joint Stock Company
Feb 2017 - Sept 2017Head of the position of Head of the Department of MicrobiologyJob Description and Skills:Study of the modern market and trends in the medical equipment market. The study of current user needs based on statistical analysis of sales in the designated direction for the reporting period. Choosing a target market. Develop a competitive advantage. Approval of the sales development plan. Company sales management. User Relationship Management. Analysis of the identified inconsistencies in the marketing policy of the trusted direction, the application of targeted corrective and preventive actions in accordance with the approved basic strategic marketing plan and sales policy.Audits of First Party in ISO 13485: 2012 (Internal) for "Diacon" Joint Stock Company.Audits (technical) of Third-party medical organizations, hospitals, medical laboratories. Compliance with the laws of professional ethics and deontology. Practical experience of the Technical audit in the field of application of Medical Devices in the sections of Laboratory Medicine and Clinical Chemistry (CCLM): Microbiology (Spain: Conda). Compliance with the Laws of professional Ethics and Deontology. Show less

"Lyubertsy district hospital № 1", Moscow Region, Lyubertsy District, Kraskovo settlement, Russia
Sept 2017 - Dec 2017Head of the Department of Clinical Diagnostic LaboratoryJob Description and Skills as a Manager:Audits of First Party in ISO 9001: 2012 (Internal) for the Department of Clinical Diagnostic Laboratory, Lyubertsy district Hospital № 1. Corrective actions on the results of appeals, written complaints of patients, as well as identified inconsistencies in non-effective interaction with the General Manager of the Hospital, Clinical departments of the Hospital. Preventive actions in order to avoid repeated appeals, written complaints of patients, as well as to avoid personnel conflicts within the entrusted Department. Organization of the Department, Staff Management, Mentoring, Scheduling night and daily duty of doctors and junior medical staff, Monitoring the execution of orders for the Department, Interaction with the General Manager of the Hospital on Public Procurement of Medical Devices, Medical Equipment, Reagents, Consumables, Office supplies and control of their spending. Interaction by the Heads of Clinical Departments regarding the repetition rate of laboratory tests and the required type of biosample. Providing advice to doctors and patients regarding the choice of the type of laboratory medical research and the use of services.Job Description and Skills as a Doctor of Clinical Laboratory Diagnostics: Biochemistry, Isoimmunology, Complete Urinalysis, Quality control of laboratory tests for the execution of the Order of the Ministry of Health of the Russian Federation No. 220 of 26.05.2003. Practical experience of Technical audit, Adaptation of reagents in the field of application of Medical Devices in the laboratory medicine section - Clinical Chemistry and Laboratory Medicine (CCLM). Compliance with the Laws of professional Ethics and Deontology. Show less

"Scientific-Practical Center of Children's Psychoneurology" Department of Health Moscow
Mar 2019 - Jul 2019Doctor by specialty Clinical Laboratory Diagnostics / Department of Clinical Laboratory DiagnosticsJob Description and Skills:Work on a project to introduce clinical pharmacokinetics and therapeutic drug monitoring in npc seizure and other drug groups, as well as chromatographic methods for determining biomarkers in biological fluids for identifying and predicting the course of neurological diseases in children. Development and adaptation of methods for chromatographic analysis in the field of therapeutic drug monitoring of anticonvulsant drugs, in order to maintain the concentration of drugs in the blood of these patients in the range of the therapeutic window and to adjust the dose of treatment with anticonvulsant drugs together with clinicians. Translation of manuals for lab equipment, writing scientific articles, methodical recommendations. Compliance with the Laws of professional Ethics and Deontology. Show less
Licenses & Certifications

Quality Management System Auditor/Lead Auditor Training Course based on ISO 9001:2008. Course A17027 is certificated by IRCA and meets the training requirements for those seeking certification under the IRCA QMS auditor certification scheme
TUV NordOct 2014
Manager/Internal auditor of Quality Management System based on ISO 9001:2008, ISO DIS 9001:2015
CERT International s.r.o.Apr 2015
Организация и стандартизация деятельности клинико-диагностической лаборатории (к качеству лабораторной диагностики через качество управления)
ЦНТИ ПрогрессNov 2014
Languages
- анАнглийский
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