Regulatory Affairs Manager

2 weeks ago

Riyadh, Ar Riyāḑ, Saudi Arabia V3international Full time

V3international is seeking an experienced ISO 9001 Compliance Officer to lead our Quality Management System (QMS). The ideal candidate will possess a strong background in quality management, regulatory affairs, and industry standards. They will be responsible for ensuring our QMS meets all applicable regulatory requirements, including those set by ISO 9001 standards.

Key Responsibilities
  1. Regulatory Compliance: Ensure that our QMS meets all applicable regulatory requirements, including those set by ISO 9001 standards.
  2. QMS Development: Develop, implement, and maintain the company's QMS, aligning it with industry best practices and regulatory requirements.
  3. Internal Audits: Conduct regular internal audits to evaluate the effectiveness of our QMS, identify areas for improvement, and ensure adherence to established standards.
  4. Process Optimization: Collaborate with cross-functional teams to streamline processes, reduce waste, and enhance operational efficiency and effectiveness.
  5. Quality Assurance Policies: Develop, implement, and manage quality assurance policies, procedures, and standards to ensure product/service quality and regulatory compliance.
  6. Risk Assessments: Conduct risk assessments, root cause analyses, and corrective/preventive actions to address quality issues.
  7. Audit Coordination: Act as the primary point of contact for external audits and assessments and prepare documentation to support audit findings and compliance.
  8. Training and Support: Provide training and support to staff on quality management principles, practices, and procedures.

Requirements

  1. Bachelor's Degree in Business Administration, Quality Management, Engineering or a related field.
  2. Minimum of 8 years of experience in quality management within an engineering consultancy environment, leading QMS initiatives and maintaining compliance with ISO standards.
  3. Proven leadership skills in managing quality teams, with effective communication and interpersonal skills across teams, and the capacity to handle multiple projects simultaneously.
  4. Strong knowledge of quality assurance methodologies and tools, along with excellent analytical and problem-solving skills.
  5. Certification in ISO 9001:2015 Lead Auditor/Implementer is a must. Additional certifications such as Lean Six Sigma Green Belt or Black Belt, ASQ or equivalent are highly desirable.
  6. Membership in CQI and IRCA is an asset.
  7. Excellent English Language Skills (both written and spoken).
  8. Strong computer skills, including proficiency in quality management software and Microsoft Office Suite.

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