Regulatory Compliance Expert

1 week ago

South Dublin, Ireland beBeeQuality Full time €45,000 - €55,000
Compliance Specialist Role Overview

We are seeking a highly skilled Quality Compliance Specialist to join our team in South Dublin. The successful candidate will be responsible for ensuring compliance with Good Distribution Practice (GDP) and regulatory requirements across pharmaceutical and medical device operations.

The role involves maintaining Regulatory Licenses, Managing Pharmacovigilance and Vigilance Activities, Handling Audits and CAPAs, and ensuring up-to-date Documentation and Training Programs. You will also support compliance with MDR/IVDR, oversee Change Control Processes, and ensure products meet Quality Standards before distribution.

The ideal candidate will have a strong background in GDP, GMP, MDR, IVDR, and Local Regulatory Framework, as well as experience in Regulatory, Medical information or Pharmacovigilance. A Qualified Pharmacist and Responsible Person eligibility is required.

Duties and Responsibilities:
  • Oversee Good Distribution Practice (GDP) activities for pharmaceutical and medical device products
  • Ensure temperature control and environmental monitoring of storage and distribution areas
  • Manage quality operations, including deviation/NC handling, root cause analysis, and implementation of corrective and preventive actions (CAPAs)
  • Perform risk assessments for distributed products and processes in line with regulatory and company standards
  • Maintain and control documentation, including SOPs, records, and batch release documents
  • Lead and participate in internal and external audits, including preparation, execution, and follow-up on findings
  • Prepare, submit, and maintain facility licenses, registrations, and renewals with national and international regulatory bodies
  • Oversee compliance with Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) requirements
  • Monitor regulatory updates and assess business impact (regulatory intelligence)
  • Review and approve product labelling, promotional materials, and advertising to ensure regulatory compliance
  • Manage pharmacovigilance and medical device vigilance activities, including adverse event reporting and follow-up
  • Handle product complaints and coordinate recalls in line with regulatory expectations and internal procedures
  • Oversee validation of systems, equipment, and processes involved in distribution
  • Ensure compliance with data integrity
  • Develop, maintain, and deliver training programs to ensure all staff comply with GDP, GMP, and quality policies
  • Ensure training records are complete and up to date
  • Qualify and manage suppliers and third-party service providers, including audits and performance monitoring
  • Support warehousing operations to ensure GDP compliance, including good housekeeping, pest control, and material handling
  • Ensure that pharmaceutical and medical device products meet quality and regulatory standards prior to release for distribution
  • Manage the change control process for systems, products, and procedures, assessing potential risks and regulatory impacts
Requirements:
  • Qualified Pharmacist
  • Responsible Person eligibility
  • 1-3 Years working in a similar role; Quality, Compliance (Pharma / Medical Device Business)
  • Auditor Certified (e.g., ISO 9001 and/or ISO 13485 or Pharma Equivalent)
  • Strong knowledge of GDP, GMP, MDR, IVDR, and Local Regulatory Framework
  • 1-3 years' experience in Regulatory, Medical information or Pharmacovigilance

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