Snr Quality & Regulatory Specialist

Job Description

POSITION TITLE:
Senior Quality & Regulatory Specialist
DEPARTMENT:
Regulatory Affairs
COMPANY:
Henry Schein Ireland
LOCATION:
Dublin
REPORTS TO:
Responsible Person Ireland dotted Line Senior Quality & Regulatory Manager UK & Ireland

GENERAL SUMMARY:
The Senior Quality & Regulatory Specialist is responsible for supporting the Responsible Person (RP) in the management and continuous improvement of Quality, Regulatory, and Environmental Management Systems (IMS) for Henry Schein Ireland and the UK. Operating in compliance with EU Good Distribution Practice (GDP) and applicable regulatory frameworks, the role ensures effective control, maintenance, and development of quality and environmental documentation, records, and processes.

The role holder will ensure that all quality and regulatory activities are accurately recorded within the QMS, supporting regulatory compliance and the organisation’s business quality objectives. They will provide subject matter expertise to the RP on all EU GDP–related matters and contribute to the development of a strong quality culture across both regions.

Key Responsibilities
• Support the RP in overseeing compliance with EU GDP requirements and other applicable pharmaceutical distribution regulations.
• Maintain, update, and improve the Quality and Environmental Management System (IMS) across Ireland and the UK.
• Ensure timely creation, review, approval, and control of all quality and regulatory documentation.
• Provide guidance on GDP–related processes, quality investigations, and regulatory expectations.
• Manage quality records, schedules, and monitoring activities to ensure the business meets internal and external compliance requirements.
• Drive continuous improvement initiatives and support delivery of the organisation’s quality and operational objectives.

Core Duties & Tasks
1. Support the Responsible Person (RP) in maintaining full compliance with EU GDP guidelines, including oversight of quality activities, documentation, and operational controls.
2. Manage and maintain the QMS and EMS, ensuring documentation, procedures, and controlled records are accurate, current, and compliant with regulatory expectations.
3. Coordinate internal audits for GDP, environmental, and quality processes; track corrective and preventive actions (CAPAs) to a timely completion.
4. Review, investigate, and support the closure of quality incidents, including deviations, complaints, non-conformances, and returns, ensuring root cause analysis and effectiveness checks.
5. Monitor key GDP processes, such as temperature excursions, transportation qualification, supplier and customer qualification, service provider oversight, and controlled activities.
6. Coordinate document control activities, including SOP creation, review cycles, approvals, and archiving, ensuring compliance with change control requirements.
7. Support regulatory submissions and updates, including licence variations, site updates, wholesale distribution authorisations (WDA), and communications with competent authorities as needed.
8. Deliver GDP training, support training matrix management, and ensure personnel remain competent and appropriately qualified for their roles.
9. Maintain oversight of supplier and service provider qualification, including audits, risk assessments, and ongoing performance monitoring.
10. Prepare for and support the RP in external regulatory inspections and customer audits, ensuring readiness and timely follow-up on actions raised.
11. Compile quality metrics and contribute to Management Review meetings for both Ireland and the UK.
12. Support continuous improvement initiatives, including process optimisation, documentation enhancements, and quality culture development across both regions.
13. Other projects and tasks as required.

In addition to the essential duties and responsibilities listed above, all positions are also responsible for:
• Meeting company standards pertaining to quantity and quality of work performed on an ongoing basis, performing all work-related tasks in a manner that is in compliance with all Company policies and procedures.
• Adhering to Company policies, procedures, and directives regarding standards of workplace behaviour in completing job duties and assignments.
Qualifications:
o Bachelor’s degree in Regulatory Affairs, Life sciences/Environmental Sciences or related field.
o Or, demonstratable, qualified by experience, Senior level Quality and Regulatory Specialist knowledge of medical/pharmacy industry.
Specialised Knowledge areas:
o Extensive Regulatory Affairs and Quality System experience, preferably in the medical device industry and or pharmaceutical industry
o Managing compliance to/working within ISO 9001 and or ISO 13485 quality management systems
o Managing compliance to/working within EU/UK Good Distribution Practice requirements
o Communicating with Regulatory Authorities and coordinating compliance inspections
o MDD 93/42/EEC / EU MDR 2017/745 compliance requirements
o Quality Management System compliance assessments and continuous improvement for ISO 9001, GDP, MDD/MDR requirements

Essential Skills:
o Ability to drive actions to completion
o Experience of customer verification, supplier monitoring systems and requirements
o Risk Management principles and ability to implement and maintain routine QRM program
o Management of Licenses and Approvals needed for pharmaceutical, medical devices, and consumable products

Henry Schein is committed to the principle of equal opportunities in employment in all spheres of its operation. Henry Schein UK Holdings strives to operate a policy of equal opportunity and not discriminate against any person gender, race, colour, nationality, ethnic or national origin, religion, sexual orientation, marital status, disability, age or any other characteristic protected by law.