Mgr, cQA RA

This is where  your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride.  Country Quality Assurance & Regulatory Affairs Manager UK, Ireland & Malta We are looking for an experienced Country Quality Assurance (CQA) & Regulatory Affairs (RA) Manager to lead our Quality and Regulatory function across the UK, Ireland and Malta. In this pivotal leadership role, you will be responsible for shaping and executing regulatory strategies that support our product portfolio while ensuring a robust and compliant Quality Management System (QMS) across the region. You will provide strategic direction, operational oversight, and expert guidance on quality and regulatory matters, working closely with cross-functional and global teams to support business objectives and maintain compliance with applicable regulations. Reporting as a key leader within the organisation, you will also manage and develop the UK, Ireland and Malta CQA & RA team, driving a culture of quality, compliance and continuous improvement.

Regulatory Affairs Develop and execute regulatory strategies that support business goals, including new product launches and lifecycle management of marketed products. Lead regulatory activities for designated product portfolios, including pharmaceuticals and medical devices. Identify regulatory risks and implement effective mitigation plans. Monitor evolving regulatory requirements and ensure ongoing compliance with corporate policies and external regulations. Perform gap analyses of regulatory documentation and recommend practical solutions and improvements. Track regulatory submissions, approvals and documentation through effective internal systems and processes. Prepare, review and approve product labelling, promotional materials and Standard Operating Procedures (SOPs) to ensure compliance with local regulations. Build and maintain strong relationships with regulatory authorities. Collaborate closely with local marketing, commercial teams and global stakeholders to ensure regulatory deliverables align with business objectives. Provide expert regulatory guidance to cross-functional project teams. Quality Assurance Lead the implementation, maintenance and continuous improvement of the local Quality Management System. Ensure compliance with Corporate Quality policies, EU GDP, EU GMP, ISO 9001, ISO 13485, MDR and other applicable local regulations. Monitor quality performance and regulatory compliance across distribution and commercialisation activities. Support internal and external inspections and audits, including responses to observations and tracking corrective actions. Develop and manage local self-inspection, training and customer eligibility programmes. Coordinate field actions, including recalls and safety notices. Support complaint handling processes, including the review of customer communications and investigation activities. Partner with Pharmacovigilance, Warehouse & Distribution, Technical Services and Commercial teams to maintain strong quality oversight. Leadership & Stakeholder Management Lead, coach and develop the UK, Ireland and Malta CQA & RA team. Represent Quality and Regulatory Affairs within global, regional and cross-functional projects and initiatives. Drive collaboration across multiple