QA Regulatory Affairs Specialist

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

QA Regulatory Affairs Specialist

Why Join?

• Competitive salary and comprehensive benefits package.


• Opportunity to work within a well-established, highly regulated manufacturing environment.


• Exposure to a broad range of regulatory, quality, and compliance activities across the product lifecycle.


• Collaborative culture with strong cross-functional engagement across Quality, Manufacturing, Technical Operations, and Supply Chain.


• Ongoing professional development and career progression opportunities.


• The chance to make a meaningful impact on product quality, regulatory compliance, and continuous improvement initiatives.

Key Responsibilities

Regulatory & Quality Operations

• Prepare and maintain regulatory documentation to support product registrations, variations, renewals, and responses to regulatory authority requests.


• Coordinate and review stability data and associated reports to support product lifecycle activities and regulatory submissions.


• Generate and maintain stability documentation and related reports using internal quality systems.


• Review and approve quality documentation, including product specifications, quality control documentation, certificates, and manufacturing records.


• Provide regulatory and compliance guidance to internal stakeholders regarding approved product documentation and quality requirements.


• Manage change control activities and assess the potential regulatory impact of proposed changes.


• Support the preparation and maintenance of site and product regulatory documentation.


• Assist with internal audits, quality system reviews, and continuous improvement initiatives.


• Participate in quality risk management activities and support regulatory compliance assessments.


• Review product documentation associated with manufacturing, packaging, and supply chain partners to ensure ongoing compliance.


• Support product quality review activities and contribute to periodic quality reporting requirements.


• Assist in the review and management of corrective and preventive actions (CAPAs) and related quality records.


• Participate in cross-functional meetings and provide regulatory and quality input to support business objectives.


• Support compliance with applicable regulatory requirements, industry standards, and company quality procedures.