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Legal & Compliance · Job description

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.

GCC postings
2
Active markets
1
Typical experience
5+ years
In brief

A Site Quality and Regulatory Specialist in the GCC region requires iso, excel, leadership, analytical, time management. Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations. This role is in demand across the Gulf Cooperation Council countries.

Salary snapshot

What a Site Quality and Regulatory Specialist earns in the UAE

Median monthly gross in AED for a mid-level Site Quality and Regulatory Specialist. See the full breakdown by country and seniority.

25th percentile
16,000
Median
24,000
75th percentile
35,000
See salary ranges →
Key responsibilities
  • 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.
Required qualifications
  • — 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
Education requirements
  • — Professional Certification

Required skills

isoexcelleadershipanalyticaltime managementdata analysiserpaudit

Preferred skills

compliancesix sigmaleanReading ComprehensionActive ListeningWritingSpeakingCritical ThinkingActive LearningLearning StrategiesMonitoringSocial Perceptiveness

Tools & technologies

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

Hiring companies we see

  • Dupont

Hired across

  • saudi
FAQ

  • What does a Site Quality and Regulatory Specialist do in the GCC?

    A Site Quality and Regulatory Specialist in the GCC performs core duties related to iso, excel, leadership, adapted to the regional business environment and regulatory framework.

  • What qualifications do I need to be a Site Quality and Regulatory Specialist?

    Typically a Professional Certification is required, with 5+ years of experience in the field.

  • What is the demand for Site Quality and Regulatory Specialist in the GCC?

    The role is actively hired across saudi, with consistent demand from both local and multinational employers.

  • What skills are needed for a Site Quality and Regulatory Specialist role?

    Key skills include iso, excel, leadership, analytical, time management, data analysis, along with strong communication and teamwork abilities.

  • Do I need Arabic to work as a Site Quality and Regulatory Specialist in the GCC?

    Arabic language proficiency is often preferred but not always required. It depends on the employer, sector, and client-facing nature of the role.

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