Regulatory Affairs Manager

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

Job summary

Abbott seeks a Regulatory Affairs leader to drive strategy across EU/EFTA, UK, Region East and Türkiye markets, ensuring compliance, market access, lifecycle management, and risk governance.

You will lead cross-functional teams, implement evolving regulatory requirements, engage with authorities, and act as an RA SME for promotional material review and DOA considerations.

Qualifications

• Proven experience in IVD or similar industry.
• Significant experience working in international projects.
• Fluent in English (written and spoken).
• Strong leadership and project-management capabilities.

Responsibilities

• Ensure activities comply with quality system requirements.
• Perform product notifications/registrations in assigned countries.
• Lead regulatory strategies and governance activities across regions.
• Represent Regulatory Affairs in audits and with authorities.
• Coordinate with trade associations and regulatory authorities to determine compliance actions.

Skills

Project management

Negotiation skills

Leadership

Communication skills

Independent working

Attention to detail

Education

Degree in Medicine, Biology, Chemistry or Similar

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.

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