Regulatory Affairs Specialist
We are currently recruiting for a Regulatory Affairs Specialist to join our client's team based in County Offaly, specializing within the Healthcare Distribution Industry.
This is an exciting opportunity to be part of a growing and innovative company in the healthcare sector.
The successful candidate will report directly to the Managing Director and enjoy autonomy in ensuring all products meet and exceed internal and external regulatory standards, contributing to the company's long-term success.
This is a permanent position with an immediate start.
Responsibilities:
* Identifying if products are compliant or non-compliant with all regulatory requirements within the client's current market and cooperating with non-compliant potential suppliers.
* Managing regulatory changes connected to UKCA and MDR and monitoring changing or evolving global regulations.
* Ensuring all products and paperwork are audit-ready for customers, HPRA assurance, WHO inspections, and supplier audits.
* Leading strategic quality improvement projects that strengthen the company's long-term success.
* Overseeing Design Control, Change Control, Risk Management, Product Vigilance, and Document Control Systems.
Desired Skills & Experience:
* A minimum of 3 years of experience in a regulatory position within the medical device/healthcare industry.
* Qualification in Regulatory Affairs or another related field.
* A self-starter who can operate with minimal supervision.
* Strong knowledge of ISO, MDD, MDR & CE/UKCA.
* A strong sense of time and task management and excellent attention to detail.
* A systematic approach to reviewing processes and leading change and continuous improvement.