Regulatory Affairs Manager in Maidenhead

## Regulatory Affairs ManagerCandidatar-se: United Kingdom - Maidenhead: Tempo Integral: Publicado hoje: Data de término: 12 de novembro de 2026 (6 dias restantes para se candidatar): 31166545Descritivo de CargoPrimary Objective of Position* Leads Regulatory Affairs strategy and activities across assigned EU/EFTA, UK, Region East, and Region Türkiye markets, ensuring regulatory compliance, market access, lifecycle management, and effective management of regulatory risk.* Leads assessment and implementation of evolving regulatory requirements, engaging with regulatory authorities and trade associations to determine compliance strategies and communicate business impact.* Provides regulatory leadership and guidance to commercial and cross-functional teams to support compliant business activities, market access, and lifecycle management.* Acts as Regulatory Affairs lead and designated backup across assigned regional markets, ensuring continuity of regulatory support and compliance oversight.* Develops and executes regulatory strategies for registrations, promotional review, performance studies, customer and tender support, and regulatory governance activities, including DOA requirements.* Provides leadership and direction to regulatory colleagues across assigned markets, driving collaboration, capability development, accountability, and consistent execution of regulatory activities.Major Accountabilities* Ensures that all activities are performed in compliance with quality system requirements.* Reviews regulations from the assigned area countries and elevates according to CDx specific elevation process; assesses for impact and initiates and supports implementation action plans as needed; provides input into draft regulations to trade associations or competent authorities* Responsible for following of the implementation of regulatory compliance as required by international & local regulations and Abbott policies and procedures.* Performs product notifications/registrations in the assigned countries, following country-specific requirements, processes and timelines* Acts as a primary contact for country regulatory Authorities* Cooperates with key trade Associations* Supervises process for responding to customer and tender requests; provides responses to requests as needed* Acts as an SME for EMEA Promotional material review process* Performs approval of labelling and Ad Promo material in own native language* Responsible for obtaining and maintenance of regulatory approval of all Core Diagnostics and Molecular Diagnostics products intended for distribution in Region East assigned countries.* Executes tasks required for regulatory compliance in areas of product notification/ registration, responding to customer and tender requests, promotional material approval in the assigned countries, performance evaluation and DOA distribution* Ensures DOA distribution requirements are met in assigned countries* Ensures performance study requirements are met guidance, notifications, submissions, follow-up with authorities and ethic committees.* Supporting communication among divisions, dealers and health authorities to be able to get product approvals without any damage to given timelines* Ensures that knowledge and experience acquired during their professional life is transferred to other team members* Perform /act as backup for Registration / notification process in the assigned countries* Perform above mentioned activities for Abbott divisions specified in service agreements* Represents RA in audits.Education and Background* Scientific background (Degree in Medicine, Biology, Chemistry or Similar* Proven experience in IVD or similar industry* Significant experience working in an international work environment or on international projects* Project management and negotiation skills* Fluent in English (written and spoken)* Strong communication skills* Ability to work independently, with attention to detail* Knowledge of PC- and internet-based applications* Leadership Skills**The base pay for this position is**N/AIn specific locations, the pay range may vary from the range posted.Família de CargoRegulatory OperationsDivisãoCRLB Core LabLocalidadeUnited Kingdom > Maidenhead : Abbott HouseLocalidades AdicionaisTurno de TrabalhoStandardViagemNoVigilância médicaNot ApplicableAtividades de trabalho significativasNot Applicable #J-18808-Ljbffr