Regulatory Affairs Specialist
We are recruiting for a Regulatory Affairs Specialist to join our client in County Offaly, Ireland.
The ideal candidate will have a minimum of 3 years' experience in regulatory affairs within the medical device/healthcare industry.
This is a permanent position with an immediate start and an estimated salary of €60,000 - €80,000 per annum.
Key Duties & Responsibilities:
* Identify compliance or non-compliance with regulatory requirements
* Manage regulatory changes connected to UKCA and MDR
* Ensure products and paperwork are audit-ready
* Lead quality improvement projects
* Oversee Design Control, Change Control, Risk Management, Product Vigilance, and Document Control Systems
* Manage assessments of device/quality systems changes
Requirements:
* Minimum 3 years' experience in regulatory affairs
* Qualification in Regulatory Affairs or related field
* 'Self-starter' with minimal supervision
* Strong knowledge of ISO, MDD, MDR, and CE/UKCA
* Excellent time management and attention to detail
* Systematic approach to reviewing processes and leading change
About Us:
Our client is a leading company in the healthcare distribution industry, currently experiencing growth and innovation.