Associate Regulatory Affairs Director

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 .

#J-18808-Ljbffr