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

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

Job family

Regulatory Operations

Divisione

CRLB Core Lab

Sede di lavoro

United Kingdom > Maidenhead : Abbott House

Sedi di lavoro ulteriori

Turni

Standard

Viaggiare

No

Controllo medico

Not Applicable

Attività lavorative significative

Not Applicable