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PARTHIV SHAH
18417 98th
Place N, Maple Grove, MN 55311
(347)-685-5258, parthiv.mn@gmail.com
Profile:  Regulatoryand compliance managementprofessionalwithexperience inmedical
device industry specializedinsoftware devices.
 Proficientatdevelopingandimplementingregulatorystrategiesto achieve
businessstrategicgoals.
 Proventrack recordwithUS FDA and otherglobal regulatorybodiesfor timely
approval of new and modified existingmedicaldevices anddealingrecall issues.
 Effective incorporate andcross-functionalactivities: regulatorysubmissions,
compliance,quality,clinical,andprocessimprovement.
Education:  M.S. – RegulatoryAffairs and Services*
St. CloudState University,MN
(*All required coursework and project submitted. Final defense of projectis pending)
 M.S. – Electrical Engineering
San Jose State University,CA
 B.S. – Instrumentationand Control Engineering
Gujarat University,India
Key
Achievements:
 510(k) Clearances:
ElevenUSFDA 510(k) clearancesin last4 years(successratio100%).

K151115 (firstauthor,projectmanager,FDA contact)

K150104 (firstauthor,projectmanager,FDA contact)

K150738 (firstauthor,FDA contact)
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K150258 (firstauthor,projectmanager,FDA contact)
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K143079 (firstauthor,projectmanager,FDA contact)
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K141302 (firstauthor,projectmanager,FDA contact)

K140395 (firstauthorforpre-submissionpackage (meeting) and510(k)
notification,projectmanager,FDA contact)

K122578 (firstauthor,projectmanager)

K122136 (firstauthor,projectmanager)

K121213 (secondauthor,firstauthorforFDA questions,projectmanager)

K112531 (secondauthor)
Note:Inadditiontothe 510(k)s listedabove,one more isinthe review
processwiththe agency.
 Outside US Submissions:
Successfullyregistered andmaintained medical deviceproducts/licenses in
the followingcountries:
 EU:
 Responsible forregulatoryportionduringNotifiedBody audits(BSI),
- All auditspassedwithoutanyfindings.
 Managed listingof productswithGerman competentauthority.
 Maintained technical files andDoCs (2010 – 2013).
 RegisteredproductsinItalianNSISdatabase.
 Australia / NZ:
 Managed technical filesandDoCs(2010–2013).

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 Canada:
 Responsible forall license amendmentbyFax-backorClass II
license amendmentapplicationswithHealthCanada.
 China:
 Managed multiplenew productregistrations andre-registration
projectswith CFDA.
 Singapore:
 Managed multipleclass IIandI product registrationswithHSA.
 Other countries:
 Experience in productregistrationinSouthKorea,Ukraine,Russia,
Saudi Arabia,Turkey,Algeria, Tunisia, andMorocco.
 Recalls:
 Submitted five (5) MDRreportsto the FDA.
 Successfully closedtwo (2) openrecallswiththe FDA.
 Providedprojectmanagementresponsibilityforinitiatingfew
recalls,whichincluded:Riskevaluation,recall letterdraft,
notificationtothe customer,distributorsandregulatorybodies.
 Providedmonthlyrecallstatusreporttothe US FDA Minneapolis
districtoffice.
 Regulatory Audits:
Successfullyrepresentedregulatoryaffairsdepartmentforthe following
audits:
 NotifiedBody Audits:
 Successfullylead three(3) regulatory auditswith BSIwhichended
withoutany findingsorobservations.
Job History:  Sr. Regulatory Affairs Specialist (February2012 – current)
Regulatory Affairs Intern (June 2011 – February 2012)
Vital Images,Inc. - A ToshibaMedical SystemGroupCompany,Minnetonka,MN
 Maintained FDA listing and registration database.
 Authored regulatory plan for each projects to determine regulatory
pathway and provide complete regulatory assessment of new products
and product changes and managed CFG applications and certificates.
 RegisteredproductsinEU,Canada,Australia,New Zealand,Singapore,
China,Russia,Ukraine,Turkey,Tunisia,Morocco,Algeria,SouthKorea,
and Saudi Arabia.
 Managed andsubmitted Ten(10) 510(k) notificationstothe FDA.
 Secondauthorof Two(2) 510(k) notificationstothe FDA.
 Submittedfive (5) MDRs.
 Managed andinitiatedfive(5) recalls,whichincludeddraftingof recall
letter,initialnotificationtothe requiredregulatorybodies.
 Provided monthlystatusreporttorequire regulatoryagencies.
 Successfullyclosedtwo(2) recalls.
 Reviewedproductlabelingandadvertising.