QA Regulatory Affairs Specialist

DPS Group; Dublin; On-site; EUR 60,000 - 90,000; Full time

Benefits offered by this job

Competitive salary

Comprehensive benefits package

Job summary

DPS Group in Ireland is seeking a QA Regulatory Affairs Specialist to lead regulatory compliance activities across product lifecycle. You will collaborate with Quality, Manufacturing, Technical Operations and Supply Chain to ensure regulatory readiness and continuous improvement.

The role offers exposure to registrations, variations, renewals, CAPA, change control and internal audits within a highly regulated manufacturing environment.

Qualifications

• Regulatory documentation experience.
• Stability data review and reporting.
• Quality documentation review and approval.
• Change control and CAPA processes.

Responsibilities

• 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 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.

Skills

Regulatory compliance

Quality systems

Documentation management

CAPA management

Change control

Cross-functional

Collaboration

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.