Regulatory Affairs Director for Global Compliance

6 days ago


Edinburgh, Edinburgh, United Kingdom IQVIA Full time
Job Title: Regulatory Affairs Director for Global ComplianceCompany Overview:

IQVIA Laboratories is a global leader in drug discovery and development laboratory services, offering a comprehensive suite of central laboratory and specialty biomarker services.

Estimated Salary:

$120,000 - $180,000 per year, depending on experience.

Job Description:

This leadership-level position will oversee regulatory compliance within the IQVIA Laboratories' Central Laboratories functions, ensuring ongoing adherence to global regulations and standards.

Key Responsibilities:
  • Evaluate and implement regulatory strategies to ensure compliance with current global requirements, including IVDR and FDA LTD regulations.
  • Develop and manage a central repository of regulatory compliance status and documentation.
  • Support customer audits and inspections by providing documentation on procedures surrounding regulatory compliance.
  • Collaborate with internal stakeholders and third-party providers to assess compliance and provide guidance on solutions.
Required Skills and Qualifications:
  • At least 10 years of experience in the clinical trial or medical device domain, with a deep understanding of current global regulatory requirements.
  • Excellent customer management and relationship-building skills.
  • Strong organizational and project management skills, with proficiency in Microsoft Office and LIMS systems.
  • Demonstrated knowledge of medical and clinical research terminology, as well as global regulatory requirements for conducting clinical trials in central laboratories.
Benefits:
  • Work-Life Balance and positive well-being.
  • Continuous career development and growth opportunities.
  • Variety of therapeutic areas and collaborative team environment.
  • Access to cutting-edge technology and innovative processes.


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