Regulatory Affairs Manager

Abbott Laboratories; Thatcham; On-site; GBP 90,000 - 130,000; Full time

Job summary

Abbott seeks a Regulatory Affairs leader to drive strategy and activities across EU/EFTA, UK, Region East, and Region Türkiye. You will ensure regulatory compliance, market access, and lifecycle management while guiding cross-functional teams and engaging with authorities.

The role requires experience in IVD or related industries, strong leadership, and excellent communication in English. You will back up country regulatory activities and work across multiple markets to maintain timelines and

Qualifications

• Fluent in English (written and spoken).
• Strong communication skills are essential for cross-functional collaboration and regulatory interactions.
• Project management and negotiation skills are required for leading regulatory initiatives.
• Experience in IVD or similar industry with exposure to international markets is preferred.
• Leadership and ability to drive compliance within cross-functional teams.

Responsibilities

• Lead regulatory strategy and lifecycle management across assigned markets.
• Interact with regulatory authorities and trade associations to determine compliance approaches.
• Provide regulatory leadership to commercial and cross-functional teams.
• Act as regulatory lead and backup across regions to ensure continuity.
• Develop and execute regulatory strategies for registrations, promotional review, and DOA requirements.
• Drive collaboration and capability development within the regulatory team.

Skills

Fluent English

Strong communication

Project management

Negotiation skills

Independent work

PC and internet applications

Leadership skills

Education

Degree in Medicine, Biology, Chemistry or similar

Experience in IVD or similar industry

International work experience

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