Administrative Compliance Specialist

3 days ago

Dublin, Dublin City, Ireland beBeeQuality Full time €40,000 - €55,000
Job Overview

The Quality & Regulatory Administrator role is a key position within our organization, responsible for supporting the Quality, Compliance and Risk Management (QCRM) team. The primary purpose of this role is to ensure we meet and exceed our contractual and regulatory obligations, while providing best practice in QMS.

Key Responsibilities
  • Identify and manage regulatory requirements within Medical Device Regulation, ensuring understanding and application of legislation across all businesses.
  • Review and approve regulatory documentation for new vendors and products, maintaining accuracy and compliance.
  • Record and monitor product classification, identifying registration or licencing requirements and ensuring timely execution.
  • Manage and oversee inbound queries from suppliers, customers, internal stakeholders and competent authorities, ensuring prompt and effective resolution.
  • Contribute to preparation of Key Performance Indicator (KPI) reporting for the team, highlighting areas for improvement and growth.
  • Support administrative tasks as required, fostering collaboration and efficiency.
  • Assist in carrying out internal audits and preparing for external audits, ensuring readiness and compliance.
Requirements
  • Experience working within a Regulatory Affairs role within Medical Devices/Pharma Distribution, showcasing expertise and knowledge.
  • Understanding of MDR Regulation 2017/745, ISO 9001 and GDP, demonstrating grasp of regulatory frameworks.
  • Strong communication, interpersonal and prioritizing skills, enabling effective collaboration and decision-making.
  • Experience with technology platforms used for query management, enhancing efficiency and productivity.
  • Keen attention to detail, ensuring accuracy and quality in work.
  • Strives for continuous improvement, embracing learning and development opportunities.
  • Hold a valid Working Permit and Full Clean Driving License, meeting essential requirements.
Our Approach

We operate as a unified team, leveraging diverse specialties to make swift, collaborative decisions and embrace progress over perfection. We prioritize compliance and risk management to ensure the best outcomes for patients and partners, supported by our innovative portfolio and commitment to sustainability.

What We Offer
  • Flexible hybrid working model, balancing face-to-face interactions with virtual working over the long term.
  • Environment that understands how intertwined work and life have become, offering support and flexibility.
Seniority Level
  • Entry level
Employment Type
  • Full-time
Job Function
  • Information Technology
Industries
  • Pharmaceutical Manufacturing

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