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for Regulatory Affairs Specialist-Pharma/Medical Device Industry

2.00 to 6.00 Years   Bangalore   27 May, 2023
Seven Consultancy
Job LocationBangalore
EducationNot Mentioned
SalaryNot Disclosed
IndustryRecruitment Services
Functional AreaFinance / Accounts / TaxGeneral / Other Software
EmploymentTypeFull-time

Job Description

    SALARY: 6LPA - 10LPA LOCATION : Bangalore, Bengaluru, Karnataka, India VACANCIES: 1 QUALIFICATION: Any Graduate/PG MALE/FEMALE: Both EXPERIENCE: 2yr - 6yr JOB DETAILS 1) Support product s registration and regulatory submissions, including but not limited to FDA 510(k), Drugs Dossiers, Technical Files, Canadian Drug/NHP and Device License Applications, and internal Letters to File . 2) Review device labeling and advertising materials for compliance with global regulations; analyze and recommend appropriate changes. 3) Review and sign off on product and manufacturing changes for compliance with applicable regulations. 4) Create and review of documents used in good manufacturing practices; monitor audits of production and quality control areas. 5) Provide expertise and guidance in interpreting governmental regulations, agency guidelines, and internal policies to assure compliance and effectiveness. 6) Draft, modify and record regulatory SOPs, WIs, etc. pertaining to regulatory requirements 7) Manage document control and provide oversight of related quality systems such as training and other electronic quality systems to ensure effectiveness. 8) Manage non conformance, corrective action preventive actions and deviation. 9) Participate with peers in the formulation of overall direction, processes, systems and talent development for the Quality organizations. 10) Create, review and approve test protocols (as needed) to support regulatory submissions. 11) Develop and support in implementation of departmental and divisional policies and procedures. 12) Create Test Reports and Test Protocols for the testing done in-house. 13) Support product registration and regulatory submissions and approvals to introduce new products in the US, EU, Canada, Australia and other markets, typically for Drugs, and Class I and II Medical Devices. 14) Manage and renew all the regulatory registrations. 15) Supervise direct reports if any 16) Other duties as assigned FUNCTIONAL AREA Regulatory affairs, Drugs regulatory affairs, documentation, quality systems, quality assurance, FDA, EU, Europe, ISO, Drugs dossiers, Canadian drug, license applications, global regulations, Protocols understanding, international regulations, Pharma regulations, Regulatory affairs manager jobs in Bangalore, Regulatory affairs specialist jobs in Bangalore, Jobs for drugs regulatory affairs, Jobs for international regulatory affairs, Medical recruitment agencies in Bangalore, Medical placement consultant in Bangalore, Medical recruitment agencies in Bengaluru, Medical placement consultant in Bengaluru, Medical recruitment agencies in Karnataka, Medical placement consultant in Karnataka, Medical recruitment agencies in India, Medical placement consultant in India. Apply Now,

Keyskills :
quality controlfunctionalcontinuous improvement facilitationdocumentation

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