Regulatory Affairs Manager

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

DIVISION:

CRLB Core Lab

LOCATION:

United Kingdom > Maidenhead : Abbott House

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

No

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Not Applicable