AsSenior Manager of Regulatory Affairs, you will play a key leadership role within theAcute Care & Monitoring (ACM)function, supporting regulatory activities across a diverse product portfolio.This role involves developing and executing regulatory strategies, overseeing regulatory submissions, assessing the regulatory impact of product changes, and ensuring the delivery of high-quality regulatory outcomes. You will provide leadership, guidance, and mentorship to regulatory team members, supporting their professional development and helping them navigate complex regulatory requirements.You will collaborate closely with cross-functional partners including R&D, clinical, operations, and marketing to ensure regulatory requirements are fully integrated into product development and lifecycle management. From time to time, you will represent the organisation in discussions with regulatory authorities and industry groups, supporting regulatory compliance while enabling business objectives and maintaining a competitive edge in the Acute Care & Monitoring sector.A Day in the LifeRegulatory Strategy & Product DevelopmentSupport the development and implementation of global regulatory strategies across the full product lifecycle, from R&D through commercialisation and post-market activitiesCollaborate with cross-functional teams to ensure regulatory requirements are embedded in development plans and timelinesProvide regulatory guidance on product submissions (e.g. 510(k) and similar pathways)Market Access & SubmissionsOversee the preparation, review, and submission of regulatory filings in the US and EULiaise with regulatory authorities (e.g. FDA, Notified Bodies) to facilitate approvals and resolve regulatory issuesTeam Leadership & DevelopmentManage regulatory resources across assigned product programmes, aligning activities with departmental prioritiesSupport team structure, talent development, and professional growthMentor and coach team members to build regulatory expertise and leadership capabilityRisk Management & ComplianceIdentify potential regulatory risks and contribute to the development of mitigation strategiesStay informed of evolving regulatory requirements and trends, providing timely guidance to teamsBusiness InitiativesContribute regulatory expertise to business initiatives, including due diligence for new ventures and partnershipsKey Skills & ExperienceLevel 8 degree in a scientific or engineering discipline with a minimum of 7 years' experience in medical device regulatory affairs, including 5+ years in a leadership role (direct management and/or mentorship),ORAn advanced degree with a minimum of 5 years' experience in medical device regulatory affairs, including 5+ years in a leadership roleProven leadership experience within regulatory affairs, with a track record of managing teams and supporting departmental goalsStrong knowledge of the global regulatory landscape and experience interacting with regulatory authoritiesExperience supporting medical devices across the full product lifecycle, including post-market activitiesStrong business acumen with an understanding of operations and financial considerations in a regulated environmentDemonstrated ability to support process improvement and change management initiativesAbility to use data and analytics to support decision-making and clearly communicate regulatory requirementsExcellent communication, interpersonal, and influencing skills, with the ability to collaborate cross-functionally and represent the organisation externally