Abbott
Regulatory Affairs Manager
Regulatory Affairs Manager
Maidenhead, Berkshire, EnglandOn-Site
PermanentFull-Time
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Description
Primary Objective of Position
Major Accountabilities
Education and Background
- 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 and 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 ethics committees.
- Supports communication among divisions, dealers and health authorities to obtain product approvals without damage to timelines
- Ensures that knowledge and experience acquired during professional life is transferred to other team members
- Performs or acts as backup for registration/notification process in the assigned countries
- Performs 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
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