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Regulatory Affairs Manager

Posted 1 hour 43 minutes ago by Abbott Laboratories

Permanent

Full Time

Science & Technology Jobs

Berkshire, Thatcham, United Kingdom, RG180

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 independently, with attention to detail
Knowledge of PC- and internet-based applications
Leadership Skills