Regulatory Affairs Manager

JOB DESCRIPTION: Primary 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 in