Role Overview
The Quality & Regulatory Administrator will work within the QCRS team to support on Quality, Regulatory and Compliance matters. The QCRS team are a central support team to all Uniphar Medtech Businesses. The primary purpose of the role is to manage the ongoing maintenance of our regulatory requirements ensuring we meet and exceed our contractual and regulatory obligations, providing best practice in QMS.
Key Duties and Responsibilities
This job description is not an exhaustive list of duties for the position holder. It does, however, provide an indication of the main duties and responsibilities of the position.
* Responsibility for identifying regulatory requirements within Medical Device Regulation. Understanding legislation and applying it to each Business.
* Review and approval of Regulatory documentation for new vendor and product set up.
* Recording and monitoring of classification of products and identification of any registration or licencing requirements.
* Overseeing and managing inbound queries to the QCRS team from Suppliers, Customers, internal stakeholders & Competent Authorities.
* Contributing to preparation of KPI reporting for the team.
* Supporting on administrative tasks as required.
* Assisting in carrying out internal audits & preparing for external audits.
* Provide cover & support in other areas of the team during periods of high volume or annual leave.
Role Requirements
* Experience working within a Regulatory Affairs role within Medical Devices / Pharma Distribution
* Understanding of MDR Regulation 2017/745, ISO 9001 and GDP
* Strong communication, interpersonal and prioritising skills
* Experience with technology platforms used for query management
* Keen attention to detail
* Strives for continuous improvement
* Hold a valid Working Permit
* Full Clean Driving license
How We’d Like To Work Together
This role will be mainly based in our office in Northern Cross Business Park, Finglas, Dublin 11, where a flexible hybrid working model is also available. It’s important to achieve the right balance between face-to-face interactions with virtual working over the long term. In return for your flexibility, you will be joining an environment that understands how inter-twined work and life have become - and both the benefits and challenges that brings - and therefore offers a flexible, progressive way of supporting it.
Our Medtech Mindset guides our culture and work environment:
* We Go Forward Together: We operate as a unified team, leveraging diverse specialties to make swift, collaborative decisions and embrace progress over perfection.
* We Take Our Business Seriously: We prioritise compliance and risk management to ensure the best outcomes for our patients and partners, supported by our innovative portfolio and commitment to sustainability.
* We Deliver Exceptional Results: We focus on quality, customer satisfaction, and commercial success to achieve outstanding results for our patients, customers, and business.
If you have similar values and are passionate about making a meaningful impact, we invite you to join our team and help us drive forward together.
Uniphar Medtech is an equal opportunities employer.
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