Regulatory Affairs Specialist
We are currently recruiting for a Regulatory Affairs Specialist for our client based in County Offaly, who specializes within the Healthcare Distribution Industry.
The company is experiencing an exciting period of growth and innovation within the healthcare industry with new opportunities on the horizon and significant advancements in projects and capabilities.
This is a permanent position with an immediate start. The successful candidate will report directly to the Managing Director.
Your New Job
Key Duties & Responsibilities:
* Identify products that meet or exceed internal and external regulatory standards.
* Manage regulatory changes related to UKCA and MDR, and monitor evolving global regulations.
* Ensure all products and paperwork are audit-ready for customers, HPRA assurance, WHO inspections, and supplier audits.
* Lead strategic quality improvement projects to strengthen the company's long-term success.
* Oversee Design Control, Change Control, Risk Management, Product Vigilance, and Document Control Systems.
* Manage assessments of device/quality system changes.
* Act as the ISO Quality Management representative, managing correspondence with Notified Bodies to achieve certification.
What We Are Looking For
* A minimum of 3 years' experience in a regulatory position within the medical device/healthcare industry.
* Qualification in Regulatory Affairs or another related field.
* A self-starter able to operate with minimal supervision.
* Strong knowledge of ISO, MDD, MDR & CE/UKCA.
* Excellent time management, attention to detail, and ability to lead change and continuous improvement.
Salary: Estimated €60,000 - €80,000 per annum, depending on experience.