Regulatory Affairs Specialist
- Work arrangement
- Remote
- Location
- India
- Compensation
- Not disclosed
- Apply by
- April 10, 2027
About this role
Accountabilities
Supportregionalregulatoryaffairsactivitiesbycoordinatingdomesticandinternationalproductfilings,registrations,andregulatorysubmissions.
Prepare,compile,andmaintaintechnicaldocumentationandregulatoryfilesrequiredformedicaldeviceapprovals.
Coordinatetender-relatedsubmissionsandprepareresponsestoauditfindingsandregulatoryinquiries.
MonitorchangesinIndianregulationsandcommunicaterelevantupdatestoglobalregulatoryteams,includingassessmentsoftheirpotentialimpactonproductsandbusinessoperations.
Collaboratewithinternationalregulatoryrepresentativestofacilitatesubmissionsandrespondtorequestsfromhealthauthorities.
MaintainproductlistingsandestablishmentregistrationswiththerelevantIndianregulatoryauthorities.
Serveastheregulatoryaffairsrepresentativeonprojectteamsresponsiblefornewproductintroductionsandproductmodifications.
Supportcompliancewithapplicablemedicaldeviceregulations,import/exportrequirements,andBureauofIndianStandards(BIS)certificationprocesses.
Contributetocontinuousimprovementinregulatorydocumentation,submissionquality,andcomplianceprocesses.
Aminimumof2yearsofprofessionalexperienceinaClassIIorClassIIImedicaldeviceenvironment.
DemonstratedexperiencewithIndianregulatoryaffairsrequirementswithinthemedicaldeviceindustry.
WorkingknowledgeofimportandexportregulationsforITequipmentandtheBIScertificationapplicationprocess.
Strongunderstandingofregulatorysubmissions,productregistrationprocedures,andmedicaldevicecompliancedocumentation.
Excellentwrittenandverbalcommunicationskills,withtheabilitytocollaborateeffectivelywithregional,global,andcross-functionalteams.
Strongorganizationalskills,attentiontodetail,andtheabilitytomanagemultipleregulatoryactivitiesaccurately.
Abilitytotravelwhenrequired.
Experiencewithpatientmonitoringsystems,hospital-basedproducts,software,orelectronicmedicaldevices.
KnowledgeofIndianregulatorysubmissionrequirementsforClassIImedicaldevices.
FamiliaritywithqualitymanagementsystemsandISO13485standards.
Experienceworkingwithinternationalregulatoryteamsinaglobalmedicaltechnologyorganization.
Competitivebenefitspackagedesignedtosupportemployees'health,financialwell-being,andwork-lifebalance.
Healthcarecoverageandotheremployeebenefitprograms,withspecificofferingsdependingonlocation.
Paidtimeofftosupportpersonalneedsandwell-being.
Remoteworkflexibility,withtheopportunitytoworkfromhome.
Internationalcollaborationwithregionalandglobalregulatoryprofessionals.
Professionaldevelopmentopportunitiesinmedicaldeviceregulations,productcompliance,andhealthcaretechnology.
Meaningfulimpact,contributingtotheregulatoryapprovalofmedicaltechnologiesthatsupportcliniciansandpatientcare.