Senior Manager – Regulatory AffairsOverviewWe are partnering with a global medical device organisation to recruit aSenior Manager of Regulatory Affairs. This is a senior leadership role supporting a diverse portfolio of medical device products across global markets.The successful candidate will play a critical role in defining and executing regulatory strategy, leading regulatory submissions, assessing regulatory impact of product changes, and developing a high-performing regulatory team. This position requires strong cross-functional collaboration and the ability to operate effectively in a complex, highly regulated environment.Key ResponsibilitiesRegulatory Strategy & Product DevelopmentDevelop and implement global regulatory strategies across the full product lifecycle, from R&D through commercialisation and post-market activitiesPartner with R&D, clinical, quality, operations and marketing teams to ensure regulatory requirements are embedded into development plans and timelinesProvide regulatory guidance on product submissions (e.g. 510(k), technical documentation, lifecycle submissions)Market Access & Regulatory SubmissionsOversee preparation, review and submission of regulatory filings in the US and EUAct as the primary regulatory liaison with authorities such as the FDA and Notified BodiesSupport resolution of regulatory questions and issues to enable timely approvalsTeam Leadership & DevelopmentLead and allocate regulatory resources across assigned product programsBuild, mentor and develop regulatory professionals, supporting career development and capability growthProvide coaching and technical guidance on complex regulatory mattersRisk Management & ComplianceIdentify regulatory risks and contribute to mitigation strategiesMonitor changes in global regulatory requirements and communicate impacts to stakeholdersEnsure ongoing compliance throughout the product lifecycleBusiness & Strategic InitiativesProvide regulatory input into business initiatives, new ventures and partnershipsSupport regulatory due diligence activities as requiredSkills & ExperienceDegree (Level 8 or equivalent) in a scientific or engineering discipline with 7+ years' experience in medical device regulatory affairs, including 5+ years in a leadership, management, or mentorship capacityorAdvanced degree with 5+ years' experience in medical device regulatory affairs, including leadership responsibilitiesProven experience leading regulatory teams and aligning regulatory strategy with business objectivesStrong knowledge of the global medical device regulatory landscapeExperience supporting products from concept through commercialisation and post-market phasesDemonstrated business acumen within a regulated environmentExperience driving process improvement and change initiativesStrong analytical skills with the ability to use data to inform regulatory decisionsExcellent communication, stakeholder management and influencing skills