Regulatory Affairs Specialist
We are seeking a highly skilled Regulatory Affairs Specialist to join our team in County Offaly, Ireland. Our client is a leading player in the Healthcare Distribution Industry and is currently experiencing an exciting period of growth and innovation.
About the Role
The successful candidate will report directly to the Managing Director and will be responsible for ensuring all products in the distribution centre meet and exceed internal and external regulatory standards. This is a permanent position with an immediate start.
Responsibilities
* Identify if products are compliant or non-compliant with all regulatory requirements within the client's current market and cooperate with non-compliant potential suppliers.
* Manage the regulatory changes connected to UKCA and MDR and monitor changing or 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 that strengthen the company's long-term success.
* Oversee Design Control, Change Control, Risk Management, Product Vigilance, and Document Control Systems.
* Manage assessments of any device/quality systems changes.
* As the ISO Quality Management representative, manage all correspondence with Notified Body to achieve certification.
Requirements
* A minimum of 3 years experience in a regulatory position within the medical device/healthcare industry is essential.
* Qualification in Regulatory Affairs or another related field is essential.
* The desired candidate will be a self-starter and be able to operate with minimal supervision.
* Strong knowledge of ISO, MDD, MDR & CE/UKCA.
* A strong sense of time and task management and have excellent attention to detail.
* Have a systematic way to review processes and be capable of leading change and continuous improvement.
Salary
€45,000 - €60,000 per annum, depending on experience.
Location
County Offaly, Ireland.