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القانوني والامتثال · وصف وظيفي

Site Quality and Regulatory Specialist

Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations. In the GCC market, this role is actively hired across saudi with 2 recent postings.

إعلانات الخليج
2
الأسواق النشطة
1
الخبرة المعتادة
5+ years
لمحة عن الراتب

كم يتقاضى Site Quality and Regulatory Specialist في الإمارات

الوسيط الشهري الإجمالي بالدرهم لوظيفة Site Quality and Regulatory Specialist بمستوى متوسط. اطّلع على التفصيل الكامل حسب الدولة ومستوى الخبرة.

المئوية 25
16,000
الوسيط
24,000
المئوية 75
35,000
اطّلع على نطاقات الرواتب ←
المهام الرئيسية
  • 01: Ensures plant operating procedures and policies meet both ISO
  • 02Coordinate efforts associated with the preparation of regulatory documents or submissions.
  • 03Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
  • 04Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
  • 05Coordinate, prepare, or review regulatory submissions for domestic or international projects.
  • 06Prepare or maintain technical files as necessary to obtain and sustain product approval.
  • 07Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
  • 08Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
  • 09Coordinate recall or market withdrawal activities as necessary.
  • 10Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
  • 11Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.
  • 12Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
المؤهلات المطلوبة
  • — up on findings to ensure compliance with site policies /procedures/ operating discipline. Supports IMS Coordinator during Site Management System Review (facilitate MSR meetings as back
  • — solving and time management skills: understand
المؤهلات التعليمية
  • — Professional Certification

المهارات المطلوبة

isoexcelleadershipanalyticaltime managementdata analysiserpaudit

المهارات المفضّلة

compliancesix sigmaleanReading ComprehensionActive ListeningWritingSpeakingCritical ThinkingActive LearningLearning StrategiesMonitoringSocial Perceptiveness

الأدوات والتقنيات

excelerpAdobe AcrobatAnalyse-itAtrion Intelligent AuthoringDataVisionFileMaker ProFund accounting softwareHealthcare common procedure coding system HCPCSHuman resource management software HRMSIntegrated development environment IDE softwareLexisNexisMcAfeeMedical procedure coding softwareMicrosoft AccessMicrosoft Dynamics

شركات نرى أنها توظّف

  • Dupont

التوظيف حاضر في

  • saudi
اطّلع على نطاقات الرواتب ←افتح في مولّد الوصف الوظيفي ←
أدوار ذات صلة

المزيد من الأدوار في القانوني والامتثال

أدوات مجانية · 04

أدوات مجانية إضافية

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