Director of Regulatory Affairs

Director of Regulatory Affairs

The Director of Regulatory Affairs  owns the end-to-end regulatory and clinical strategy for all our Client’s product categories.
The Director of Regulatory Affairs  will be responsible for defining and executing the full regulatory pathway for each product from concept through global commercialisation & will also be responsible for regulatory submissions, dossier preparation, claims substantiation strategy, clinical evidence planning, and management of external regulatory consultants.

Key Responsibilities:

• Define global regulatory pathway per product category:
• Determine product classification strategy.
• Define regulatory feasibility before business case approval.
• Prepare, compile, and submit regulatory dossiers where required.
• Manage all correspondence with regulatory authorities.
• Maintain submission timelines aligned with launch plans.
• Define clinical evidence requirements per product.
• Determine when external clinical studies are required.
• Ensure claims are defensible based on scientific evidence.
• Establish global claims framework and guardrails.
• Review new artwork for regulatory compliance.
• Oversee new global product registrations (renewals excluded)

Key Requirements:

• Strong scientific or clinical background (advanced degree preferred).
• 10 plus years regulatory experience across multiple product categories.
• Demonstrated experience with FDA device submissions, 510(k) and/or EU MDR/CE Mark
• Experience with ISO9001:2015, ISO22716, GMP CFR 111, ISO13485.
• Experience managing regulatory submissions end-to-end.
• Experience interfacing directly with regulatory authorities.
• Demonstrated ability to balance compliance and commercial reality.

For further information please contact Loretta Flynn

[email protected]
086-1838380

INDPERM