Regulatory Affairs Manager

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.
  
  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