Job Title: Regulatory Affairs Specialist
We are currently recruiting for a Regulatory Affairs Specialist to join our client's team based in County Offaly. Our client is expanding and experiencing significant growth in the healthcare industry.
About the Role:
The Regulatory Affairs Specialist will report directly to the Managing Director and be responsible for ensuring all products meet internal and external regulatory standards. This is a permanent position with an immediate start.
Key Responsibilities:
* Identify product compliance with regulatory requirements, cooperate with non-compliant suppliers.
* Manage UKCA, MDR, and global regulatory changes.
* Ensure audit readiness for customers, HPRA assurance, WHO inspections, and supplier audits.
* Lead strategic quality improvement projects.
* Oversee Design Control, Change Control, Risk Management, Product Vigilance, and Document Control Systems.
* Assess device/quality systems changes.
* Manage ISO Quality Management correspondence with Notified Body for certification.
Requirements:
* Minimum 3 years' experience in regulatory roles within medical devices/healthcare.
* Qualification in Regulatory Affairs or related field.
* Strong self-motivation and ability to operate with minimal supervision.
* Knowledge of ISO, MDD, MDR, CE/UKCA.
* Excellent time management, attention to detail, and leadership skills.
What We Offer:
A dynamic work environment with opportunities for growth and development.