RegulatoryAffairsManagerUK&I

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. # **A Day in the Life** The Quality & Regulatory Affairs Manager for the UK and Ireland is responsible for regulatory compliance, post-market surveillance, and quality system compliance to ISO 13485 for Medtronic Ltd. This role leads the UKI QRA team and serves as the primary contact with UK and Irish regulatory agencies, including the Medicines and Healthcare products Regulatory Agency (MHRA), the Health Products Regulatory Authority (HPRA), and relevant Health Technology Assessment (HTA) bodies. The Manager provides regulatory expertise for local projects and ensures compliance with UK and EU requirements. **Responsibilities may include the following, and other duties may be assigned:** * Lead and develop the UKI Quality & Regulatory Affairs team * Own and maintain UKRP, Human Tissue Import Licence, and BioPharma Import Licence activities for Medtronic Ltd, acting as the main contact for relevant authorities * Monitor regulatory changes across the UK and EU, assess impact, and drive updates to regional and local procedures * Coordinate internal and external audits and inspections * Maintain ISO 13485 certification * Oversee Post-Market Surveillance activities in the UK and Ireland, including field safety corrective actions, notifications, execution reporting, and responses to MHRA and HPRA requests for additional information * Deploy enterprise QRA strategy and initiatives across UKI * Provide and/or coordinate local training on regulatory affairs and quality topics **Required Knowledge and Experience:** * Significant experience in Regulatory Affairs and Quality within the medical device industry * Proven leadership and people development experience * Strong communication, interpersonal, and influencing skills * Hands-on, rig