Country Quality Assurance & Regulatory Affairs Manager (Pharmaceuticals/Medical Devices)

Location: Reading, Berkshire, United Kingdom; responsibility covers the UK, Ireland and Malta

Company

hirify.global develops and delivers healthcare products and solutions focused on saving and sustaining lives.

What you will do

• Develop and execute regulatory strategies for new product launches and lifecycle management.
• Lead regulatory activities for pharmaceutical and medical device portfolios, including submissions, approvals, labelling and promotional materials.
• Implement, maintain and continuously improve the local Quality Management System.
• Ensure compliance with EU GDP, EU GMP, ISO 9001, ISO 13485, MDR and applicable local regulations.
• Support inspections, audits, complaint investigations, corrective actions, recalls and safety notices.
• Lead, coach and develop the UK, Ireland and Malta CQA & RA team while partnering with global and cross-functional stakeholders.

Requirements

• Bachelor's degree or equivalent in Pharmacy, Life Sciences or a related scientific discipline.
• Minimum 5–7 years of experience in Regulatory Affairs, Quality Assurance or a related field.
• Experience leading people, projects or cross-functional teams.
• Strong knowledge of drug and medical device regulations and Good Distribution Practices.
• Strong leadership, influencing, stakeholder management, communication, presentation and negotiation skills.
• Ability to work effectively in a multinational and multicultural environment with strong attention to detail.

Nice to have

• Master's degree and/or PhD in a relevant scientific discipline.
• Experience in a healthcare, pharmaceutical, medical device or CRO environment.
• Experience managing both pharmaceutical and medical device portfolios.

Culture & Benefits

• Competitive total compensation package.
• Professional development opportunities.
• Strong focus on work-life balance.
• Culture of courage, trust, collaboration, ownership and continuous improvement.