Poole Bay Holdings Ltd

Compliance

• Develop and deliver the PBH Group Product Compliance strategy in alignment with the overall Group Strategy.
• Identify all applicable regulatory and legal requirements across Pharmaceutical, Medical Devices and other related product categories.
• Construct and implement structured compliance plans to ensure ongoing regulatory adherence.
• Establish governance, policies and compliance controls across product lifecycles.
• Provide regular compliance reporting to the Operations Director and Board.
• Monitor regulatory changes and ensure timely implementation of required updates.
• Act as the company’s nominated Responsible Person (RP) registered with the MHRA.
• Ensure full compliance with GDP (Good Distribution Practice) requirements.
• Maintain and oversee the Wholesale Distribution Authorisation (WDA).
• Ensure appropriate GDP training, documentation and audit readiness across the business.
• Lead MHRA inspections and manage responses to regulatory findings.
• Maintain RP oversight of storage, transportation, supplier qualification and distribution controls.
• Ensure compliance of Medical Device products (including Koolpak, gloves and related ranges) with UK and EU MDR and ISO 13485 standards.
• Collaborate with our external Medical Device consultants to maintain regulatory compliance.
• Oversee technical documentation, declarations of conformity and product registrations.
• Ensure post-market surveillance, vigilance and reporting obligations are met.
• Own and maintain the Group Quality Management System (QMS).
• Ensure compliance with ISO standards including ISO 9001 and other relevant certifications.
• Plan and manage internal audits and external certification audits.
• Implement corrective and preventive actions within agreed timeframes.
• Drive continuous improvement across quality and compliance processes.

Compliance Manager