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Engineer- Medical Regulatory Affairs

4.00 to 9.00 Years   Hyderabad   02 Dec, 2022
Job LocationHyderabad
EducationNot Mentioned
SalaryNot Disclosed
IndustryIT - Software
Functional AreaGeneral / Operations Management
EmploymentTypeFull-time

Job Description

    Responsibilities may include the following and other duties may be assigned:Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspectionsPrepare, review, file, and support premarket documents for global registrations for assigned projects.Collaborate with business unit and international regulatory affairs personnel to support marketing authorizations for assigned projects.Leads or compiles all materials required in submissions, license renewal and annual registrationsRecommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory complianceMonitors and improves tracking/control systemsKeeps abreast of regulatory procedures and changesMay direct interaction with regulatory agencies on defined mattersRecommends strategies for earliest possible approvals of clinical trials applicationsSkills & ExperienceInternational Regulatory Compliance, People Management, Regulatory Compliance, Regulatory Processes,

Keyskills :
Regulatory CompliancePeople ManagementRegulatory Compliance

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