Regional QA & Regulatory Affairs Leader (UK, IE & Malta)

Baxter International Inc.; Reading; Sur place; GBP 90 000 - 120 000; Plein temps

Avantages offerts par ce poste

Competitive total compensation package

Professional development opportunities

Focus on work-life balance

Résumé du poste

Baxter International Inc. in the UK, Ireland and Malta seeks a Country Quality Assurance (CQA) & Regulatory Affairs (RA) Manager to lead Quality and Regulatory across the region. Shape regulatory strategies, ensure a robust QMS, and guide cross-functional teams to meet compliance objectives.

Lead the local CQA & RA team, drive continuous improvement, and ensure conformity with EU GDP, EU GMP, ISO standards and MDR, while collaborating with global stakeholders.

Qualifications

• Strong scientific and technical knowledge in healthcare, pharma or Medical Devices.
• Proven experience in Regulatory Affairs and Quality Assurance.
• Experience leading people, projects or cross-functional teams.

Responsabilités

• Lead Regulatory Affairs for designated product portfolios and lifecycle management.
• Oversee Quality Assurance activities and maintain the local QMS.
• Coordinate internal and external inspections and audits.
• Develop and manage cross-functional regulatory strategies with global teams.
• Coach and develop the CQA & RA team across UK, Ireland and Malta.

Connaissances

Regulatory affairs

Quality assurance

Leadership

Stakeholder management

Formation

Bachelor’s degree in Pharmacy, Life Sciences or related

Description du poste

Baxter International Inc. in the UK, Ireland and Malta seeks a Country Quality Assurance (CQA) & Regulatory Affairs (RA) Manager to lead Quality and Regulatory across the region. Shape regulatory strategies, ensure a robust QMS, and guide cross-functional teams to meet compliance objectives.

Lead the local CQA & RA team, drive continuous improvement, and ensure conformity with EU GDP, EU GMP, ISO standards and MDR, while collaborating with global stakeholders.