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Aleksey Yevdokymov

Bis 2025, Senior Regulatory Affair. Wireless medical products., Baxter International Inc.
Ratingen, Deutschland

Fähigkeiten und Kenntnisse

electrical
Projektmanagement
Telecommunications
SAP
Jde
Regulatory Affairs
Certification
type approval
spectrum allocation
EMC & Radio
medical wireless products
regulatory affair
Medical Products
Market access
Wireless Communication
C/C++
product compliance and certification
FCC
ISED Canada
Radio type approval
RED 2014/53/EU
medical directive (EU) 2017/ 745
CE-Certification
CCC
ANATEL
AIS
BSMI
GCF/PTCRB
ISO 17025
ISO16949
ISO 13485
SAR
ACMA
SRRC
ERA-GLONASS certification
attention to detail
Management
Technical project management

Werdegang

Berufserfahrung von Aleksey Yevdokymov

  • 2 Jahre und 3 Monate, Jan. 2023 - März 2025

    Senior Regulatory Affair. Wireless medical products.

    Baxter International Inc.

    Medical Device Compliance and Market Access. Regulatory Compliance and product registration as well as consulting and certifying of medical wireless components, modules and end devices. Regulatory Affairs : Radio, EMC, spectrum compliance, and wireless certification for medical products. Support for R&D, design control process, testing strategies, risk assessments, and applied standards: FDA, FCC, RED, BT SIG, ANSI 63.27, Med Directive. SAP operations for documentation and quality management under ISO13485

  • 18 Jahre, Jan. 2005 - Dez. 2022

    Testing & Certification Project Manager

    Bureau Veritas/ 7 Layers AG Ratingen, Germany

     Consultancy and services for the placing wireless and cellular products to the worldwide market including specific vehicle telematic and service applications, testing support, worldwide frequency management application. Project Management , progress reporting, project management tools, project planning and control techniques.  Including wireless products validation under FCC, RED, ISED, CE Globe-wide international standards.  e-mobility component certification  vehicle emergency system e-cal/GLONAS-ERA

  • 2 Jahre und 9 Monate, Apr. 2002 - Dez. 2004

    System Engineer /UMTS protocol test/.

    7Layers AG Ratingen, Germany

     Test cases debugging; Integration and validation.  3GPP Test cases validation for Anritsu and R&S test equipment  Writing and verification Change requests for 3GPP TSG-T1).Experience in TTCN-2/ ASN.1, test automation tools, /Using Telelogic Tau (SDT) / including automatic code generation tools development, telecom, RF protocols  3GPP Test cases validation for Anritsu and R&S test equipment,using NOKIA specific application tool.

  • 1 Jahr und 1 Monat, Feb. 2001 - Feb. 2002

    Project Engineer ( SDH ADM/WDM commissioning and testing)

    ALCATEL AG, Stuttgart,Germany

    leveling in installing , commissioning and routing traffic. Network analyzing tools.  Took part in the Alcatel projects for German domestic SDH ring:I-21 communication, KPN Quest, Viag Intercom

  • 4 Jahre und 7 Monate, Juli 1996 - Jan. 2001

    Telecommunication Engineer, Leading specialist

    RADIOCOM JSC Kiev, Ukraine

     Management of wireless paging network Service and Support Department  Wireless-radio measurement using service monitor CMS54 (ROHDE&SCHWARZ) and spectrum analyzer HP8920. Troubleshooting wireless networks, including spectrum analyzer operation. Survey, designing, install and repair RF (wireless) network system components.  Installation software and hardware application for network solution. Equipment: modems, terminal server and routers. Protocols: G703, HDSL, X25, IP, DPNs

  • 5 Jahre und 11 Monate, Aug. 1992 - Juni 1998

    R&D Engineer /electronic, measurement systems, Development /

    Academy of Science. Electrodynamic Inst. Kiev, Ukraine

    Development of electronic circuits, measurement algorithms. Hardware & software for LASER higher accuracy precision distance measurements systems; engineering research . Analog, digital IC, general-purpose digital logic, analog circuits, A/D & D/A converters, memory and standard computer system bus components & systems. Skills in "design for manufacturability" including reliability, circuit yields, turn-on procedures, self-calibration and diagnostics. EMC for components and systems.

  • 3 Jahre und 2 Monate, Feb. 1988 - März 1991

    Technical assistant

    National Technical University. Kiev, Ukraine

    Technical assistant National Technical University. Kiev, Ukraine Wireless industry  Research, construction of microwave circuits. Frequencies 0.5-8 GHz , microwave measurements & modeling. microstrip lines and antennas. RF Scientific investigation support.

  • 2 Jahre und 2 Monate, Juni 1986 - Juli 1988

    Technician /"Sgt", Radar station service/

    Ministry of Defense of the USSR / SGV . Polen, Gross Born /

    Adjustments, testing of nodes and systems of radar station, support of rocket launch, and artillery shootings. Military RF experience and military management experience.

Ausbildung von Aleksey Yevdokymov

  • 6 Jahre und 9 Monate, Sep. 1984 - Mai 1991

    Wiress., Radio engineering

    National Technical University of Ukraine 'Kyiv Polytechnic Institute'

    Development and Research :microwave, wireless Electronic circuits, optical systems, designing and development signal processing algorithms.  Available also Acceptance and Recognition certificate from German Ministerium für Innovation, Wissenschaft und Forschung des Landes Nordrhein-Westfalen,DE

Sprachen

  • Ukrainian First language

    -

  • Englisch

    Fließend

  • Russisch

    Fließend

  • Deutsch

    Fließend

  • Japanisch

    Grundlagen

  • Polnisch

    Grundlagen

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