Regulatory Affairs & Quality Compliance Specialist

Jacksonstone Recruitment Ltd; Wicklow; On-site; EUR 42,000 - 60,000; Full time

Job summary

Jacksonstone Recruitment Ltd is seeking a Regulatory Affairs/Quality Assurance professional to support regulatory, quality and operational activities related to registration, maintenance and compliance of products and processes.

You will prepare documentation for product registrations, respond to regulatory queries, maintain statutory requirements, analyse LIMS data for stability reports, review CoAs, support audits and risk assessments, and drive continuous improvement across the QMS with a

Qualifications

• GMP, quality and regulatory requirements understood and applied.
• Excellent attention to detail and strong documentation skills.
• Ability to interpret complex regulatory documentation accurately.
• Strong organisational and time-management abilities.

Responsibilities

• Prepare and maintain documentation required for registration of products and processes.
• Prepare responses to regulatory queries from authorities.
• Define and maintain statutory requirements for new products and changes.
• Retrieve and analyse LIMS data to support regulatory and stability reports.
• Review and approve Master QC and Master Process documentation, including CoAs.
• Support departments with regulatory documentation queries and ensure compliance.
• Assess regulatory impact of changes to registered documentation.
• Collaborate to prepare and maintain the Site Master File.
• Prepare Product Quality Reviews (PQRs) in line with legislation and requirements.
• Participate in internal and external audits and support audit activities.
• Participate in QMS risk assessments.
• Review APQCs weekly, and maintain related registration tables.
• Review CoAs for accuracy and regulatory compliance.
• Provide quality and regulatory input in site performance meetings.
• Maintain focus on compliance, data integrity, and continuous improvement.

Skills

Regulatory affairs

Quality management

Documentation control

Data analysis

GMP compliance

Cross-functional collaboration

Tools

LIMS

Job description

Jacksonstone Recruitment Ltd is seeking a Regulatory Affairs/Quality Assurance professional to support regulatory, quality and operational activities related to registration, maintenance and compliance of products and processes.

You will prepare documentation for product registrations, respond to regulatory queries, maintain statutory requirements, analyse LIMS data for stability reports, review CoAs, support audits and risk assessments, and drive continuous improvement across the QMS with a