Anna Stepanova

Anna Stepanova Email and Phone Number

RA Sr. Program Manager @ GE HealthCare | Regulatory Affairs, Medical Devices @ GE HealthCare
chicago, illinois, united states
Anna Stepanova's Location
Russia, Russian Federation
About Anna Stepanova

Regulatory Affairs (Medical devices, Pharmaceutical products, Food supplements and Cosmetics) since 2011.Current key responsibilities:• Regional Regulatory Affairs partner for PCS business. • Medical devices submissions.• Local and on-site type testing organizing.• ISO 13485 QMS audits. • Legislation impact assessment and influencing. • SOPs development. • Review labels, advertising, manufacturing documents to ensure regulatory compliance.

Anna Stepanova's Current Company Details
GE HealthCare

Ge Healthcare

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RA Sr. Program Manager @ GE HealthCare | Regulatory Affairs, Medical Devices
chicago, illinois, united states
Website:
gehealthcare.com
Employees:
50580
Anna Stepanova Work Experience Details
  • Ge Healthcare
    Ra Sr. Program Manager
    Ge Healthcare Mar 2024 - Present
    Moscow, Russia
    Key responsibilities:• Regional Regulatory Affairs partner for PCS business. • Medical devices submissions.• Local and on-site type testing organizing.• ISO 13485 QMS audits. • Legislation impact assessment and commenting. • SOPs development. • Review labels, advertising, manufacturing documents to ensure regulatory compliance.• Post-market surveillance
    View
  • Ge Healthcare
    Regulatory Affairs Leader
    Ge Healthcare Apr 2017 - Mar 2024
    Moscow, Russia
    Key responsibilities:• Regional Regulatory Affairs partner for PCS business. • Medical devices submissions of PCS, MR, Interventional, X-ray, SW products.• Local and on-site type testing organizing.• Legislation impact assessment and commenting. • SOPs development. • Review labels, advertising, manufacturing documents to ensure regulatory compliance.• Post-market surveillance
    View
  • Ge Healthcare
    Regulatory Affairs Specialist
    Ge Healthcare Dec 2014 - Apr 2017
    Moscow, Russia
    Key responsibilities:• Regional Regulatory Affairs partner for MR, Interventional, X-ray, SW products.• Medical devices submissions. • Local and on-site type testing organizing.• Legislation impact assessment and commenting. • SOPs development. • Review labels, advertising, manufacturing documents to ensure regulatory compliance.• Post-market surveillance
    View
  • Covidien (Medtronic Minimally Invasive Therapies Group)
    Senior Regulatory Affairs Specialist
    Covidien (Medtronic Minimally Invasive Therapies Group) Oct 2013 - Dec 2014
    Moscow, Russia
    • Regional Regulatory Affairs for all Covidien products.• Medical devices submissions. • Local type testing organizing.• Legislation impact assessment and commenting. • Review labels, advertising, manufacturing documents to ensure regulatory compliance.• Post-market surveillance
    View
  • Alcon
    Regulatory Affairs Specialist
    Alcon Apr 2013 - Oct 2013
    Moscow, Russia
    Key responsibilities:• Regional Regulatory Affairs for medical devices, pharmaceutical products, food supplements, consumer products.• Medical devices, pharmaceutical products, food supplements, consumer products submissions. • Local type testing organizing.• Legislation impact assessment. • Review labels, advertising, manufacturing documents to ensure regulatory compliance.• Post-market surveillance
    View
  • Alcon
    Junior Regulatory Affairs Specialist
    Alcon May 2011 - Apr 2013
    Moscow, Russia
    Key responsibilities:• Regional Regulatory Affairs for medical devices, pharmaceutical products, food supplements, consumer products.• Medical devices, pharmaceutical products, food supplements, consumer products submissions. • Local type testing organizing.• Legislation impact assessment. • Review labels, advertising, manufacturing documents to ensure regulatory compliance.• Post-market surveillance
    View
  • G.S. Petrov Institute Of Plastics
    Engineering Technologist
    G.S. Petrov Institute Of Plastics Oct 2009 - May 2011
    Moscow, Russia
    Key responsibilities• Design of processes and selection of equipment.• Drawings` creation. • Preparation and translation of technical documentation.

Anna Stepanova Education Details

  • Russian Chemical Technological University Named After D.I. Mendeleev
    Russian Chemical Technological University Named After D.I. Mendeleev
    Processing Engineer (Plastics And Elastomers), Translator
  • Ge Crotonville
    Ge Crotonville
    Rise Leadership Program
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Frequently Asked Questions about Anna Stepanova

What company does Anna Stepanova work for?

Anna Stepanova works for Ge Healthcare

What is Anna Stepanova's role at the current company?

Anna Stepanova's current role is RA Sr. Program Manager @ GE HealthCare | Regulatory Affairs, Medical Devices.

What schools did Anna Stepanova attend?

Anna Stepanova attended Russian Chemical Technological University Named After D.i. Mendeleev, Ge Crotonville.

Who are Anna Stepanova's colleagues?

Anna Stepanova's colleagues are Rochelle (Kragness) Pytlik, Vamshi Lingala, Anna Roche, John Hung, Weerawong Manee, Santhosh Kumar M, Ewelina Romańska-Zygo.

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