QA Regulatory Affairs Specialist - Quality & Compliance

DPS Group Global; Wicklow; On-site; EUR 60,000 - 80,000; Full time

Job summary

DPS Group Global is seeking a QA Regulatory Affairs Specialist to join our regulated manufacturing environment in Ireland. The role focuses on preparing regulatory documentation, supporting registrations and variations, and ensuring ongoing compliance across the product lifecycle.

You will coordinate stability data, review quality documentation, and provide regulatory guidance to cross-functional teams while contributing to CAPAs, audits, and site quality initiatives.

Qualifications

• Experience in regulatory and quality operations within a regulated manufacturing environment.
• Ability to interpret and apply regulatory requirements to product documentation.

Responsibilities

• Prepare and maintain regulatory documentation for registrations, variations, renewals, and authority responses.
• Coordinate stability data and reports to support lifecycle activities and submissions.
• Generate and maintain stability documentation using internal systems.
• Review and approve quality docs, certificates, and manufacturing records.
• Provide regulatory guidance to internal stakeholders on documentation and quality requirements.
• Manage change controls and assess regulatory impact of changes.
• Support site and product regulatory documentation.
• Assist with internal audits and continuous improvement initiatives.
• Participate in quality risk management and regulatory compliance assessments.

Skills

Regulatory compliance

Quality documentation

Cross-functional collaboration

Regulatory submissions

Tools

QMS awareness

Job description

DPS Group Global is seeking a QA Regulatory Affairs Specialist to join our regulated manufacturing environment in Ireland. The role focuses on preparing regulatory documentation, supporting registrations and variations, and ensuring ongoing compliance across the product lifecycle.

You will coordinate stability data, review quality documentation, and provide regulatory guidance to cross-functional teams while contributing to CAPAs, audits, and site quality initiatives.