Regulatory Manager

Location: Limerick
Employment Type: Full-Time, Permanent
Reporting To: Chief Operations Officer

About the Role

We are seeking an experienced Regulatory Manager to lead and manage the regulatory team, ensuring compliance with all regulatory and legal requirements across multiple territories. The role involves strategic oversight of regulatory activities, technical documentation management, and coordination of regulatory submissions while providing guidance and leadership to team members.

Key Responsibilities

• Lead, coach, and develop direct reports, setting clear priorities and resolving resource conflicts.
• Conduct regular team and project meetings to monitor progress, assign work, and resolve issues.
• Oversee the implementation and control of regulatory strategies within the team.
• Manage and maintain technical documentation for existing Class A and B IVD products, including conducting technical reviews.
• Administer post-market surveillance and risk management processes.
• Coordinate vigilance reporting for CE-IVD and other territories, ensuring all regulatory reporting deadlines are met.
• Manage regulatory clearance/certification for existing products and filings in new territories.
• Oversee regulatory submission timelines, identifying risks and recommending mitigations.
• Advise cross-functional teams (R&D, Manufacturing, Technical) on regulatory strategies for existing, changing, or non-conforming products.
• Maintain up-to-date knowledge of the regulatory environment and communicate changes effectively throughout the organization.
• Act as deputy Person Responsible for Regulatory Compliance, as needed.

Candidate Profile

Essential Criteria:

• BSc in Molecular Biology or relevant scientific discipline.
• Minimum 5 years’ experience in a regulatory role within Medical Devices or In Vitro Diagnostics.
• At least 2 years’ experience managing or supervising a team.
• Strong knowledge of ISO 13485 and IVDR/MDR.
• Ability to manage multiple priorities in a fast-paced environment.
• Exceptional attention to detail.
• Professional interaction skills at all organizational levels.
• Excellent written and verbal communication skills.

Desirable Criteria:

• Knowledge of Software as a Medical Device (SaMD) and related guidance/standards.
• Experience engaging with Notified Bodies or international regulatory authorities during conformity assessment processes.

Why Apply

This is a high-impact leadership role offering exposure to complex regulatory challenges across multiple markets. Ideal candidates are strategic thinkers, proactive problem-solvers, and leaders who can navigate regulatory landscapes while supporting team development and organizational compliance.