Associate Regulatory Affairs Director

2 dni temu

Warszawa, Mazovia, Polska IQVIA Pełny etat 60 000 zł - 120 000 zł rocznie

Position Summary

We are seeking a highly skilled and detail-oriented Associate Director of Regulatory Affairs to lead clinical documentation and regulatory submission activities in support of EU MDR compliance. This strategic role will oversee the preparation, finalization, and lifecycle management of clinical and regulatory documents, with a focus on services across the UK, Netherlands, and Denmark.

Key Responsibilities

Clinical Documentation & Planning

  • Lead the drafting and lifecycle management of Clinical Investigation Plans (CIP).
  • Prepare and maintain Master Patient Informed Consent (PIC) Forms in alignment with EU MDR and local regulatory requirements.
  • Develop and manage Investigational Medical Device Dossiers and Investigator's Brochures.

Safety & Risk Management

  • Draft and manage Safety Plans and oversee Safety Reporting for both prospective and post-market studies.
  • Prepare Clinical Study Progress Reports and Close-Out Reports.

Regulatory Submissions

  • Draft, finalize, and manage Master Submission Documents for:
    • National Competent Authorities
    • Ethics Committees
    • IRBs/IECs
  • Review and revise sponsor-provided submission documents to ensure regulatory compliance and consistency.
  • Prepare and manage Amendment Submission Documents for protocol or study changes.

Qualifications

  • Minimum 8 years of experience in regulatory affairs or medical device submissions.
  • Strong knowledge of EU MDR, ISO 14155, and relevant regulatory frameworks.
  • Proven experience managing multi-country clinical submissions and working with Competent Authorities and Ethics Committees.
  • Exceptional written and verbal communication skills.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more

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