Job Title: Regulatory Affairs Specialist
About Our Client
Our client, a leading company in the Healthcare Distribution Industry based in County Offaly, is experiencing an exciting period of growth and innovation.
About the Role
We are seeking a skilled Regulatory Affairs Specialist to join our team. This permanent position offers autonomy and opportunities for professional growth.
Key Responsibilities
* Ensure all products meet internal and external regulatory standards.
* Monitor regulatory changes connected to UKCA and MDR, and global regulations.
* Maintain audit-ready products and paperwork for customers and suppliers.
* Lead quality improvement projects to strengthen long-term success.
* Oversee Design Control, Change Control, Risk Management, Product Vigilance, and Document Control Systems.
* Manage assessments of device/quality systems changes.
* Promote ISO Quality Management certification through correspondence with Notified Bodies.
Requirements
* Minimum 3 years' experience in a regulatory position within the medical device/healthcare industry.
* Qualification in Regulatory Affairs or a related field.
* Ability to operate with minimal supervision and self-motivation.
* Strong knowledge of ISO, MDD, MDR, and CE/UKCA.
* Effective time and task management, with excellent attention to detail.
* A systematic approach to reviewing processes and leading change.