Associate Regulatory Affairs Director

IQVIA; Frankfurt; Vor Ort; EUR 80.000 - 100.000; Vollzeit

Zusammenfassung

A leading healthcare solutions provider is seeking an Associate Director of Regulatory Affairs in Frankfurt, Germany. In this strategic role, you will lead clinical documentation and regulatory submission activities to ensure compliance with EU MDR. You should have at least 8 years of experience in regulatory affairs, with a strong knowledge of EU MDR and ISO 14155. Excellent communication skills are essential. This position offers a competitive salary and the opportunity to work within a multi-country framework.

Qualifikationen

• 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.

Aufgaben

• Lead the drafting of Clinical Investigation Plans.
• Prepare and maintain Master Patient Informed Consent Forms.
• Draft and manage Safety Plans for clinical studies.

Kenntnisse

Regulatory affairs experience

EU MDR knowledge

ISO 14155 knowledge

Communication skills

Jobbeschreibung

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 AuthoritiesEthics CommitteesIRBs / 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 .