Regulatory Affairs Associate

Kelly Science, Engineering, Technology & Telecom; Portugal; Híbrido; EUR 25 000 - 36 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Hybrid work

13-month term with extension potential

Global MedTech environment

Resumo da oferta

Kelly Science, Engineering, Technology & Telecom is seeking a Regulatory Information Administrator (EMEA MedTech) to join our hybrid team in Portugal on a 12-month fixed-term contract. The role blends Regulatory Affairs, data management, and project coordination to support the EMEA MedTech business within a centralised information system.

The successful candidate will manage regulatory data, maintain trackers, and collaborate with cross-functional teams across regions, developing expertise in

Qualificações

• Experience in Regulatory Affairs or Regulatory Operations.
• Experience with databases or data management systems.
• Excellent English and advanced Excel skills.

Responsabilidades

• Perform Regulatory Impact Assessments using matrices and regulatory data repositories.
• Create, update, manage, and close Regulatory Affairs actions in the RIM system.
• Monitor and coordinate regulatory actions across EMEA to support submissions.
• Maintain regulatory records, reports, trackers, and system updates for country teams.
• Ensure data accuracy, consistency, and integrity across regulatory databases.
• Extract, review, and process information from internal systems and emails.
• Follow established processes to execute regulatory actions in system-based environments.
• Generate reports and support regulatory data analysis activities.
• Participate in continuous improvement of regulatory information management processes.
• Collaborate to enhance centralized regulatory database systems and reporting tools.
• Provide administrative support to the wider Regulatory Affairs team.

Conhecimentos

Excel (Pivot Tables)

Attention to detail

Organisational skills

English communication

Cross-functional collaboration

Descrição da oferta de emprego

Regulatory Information Administrator (EMEA MedTech)

Location: Hybrid – Portugal

Contract Type: 12-Month Fixed-Term Contract (FTC)

Start Date: ASAP

Extension Opportunity: Strong potential for contract extension

Overview

An exciting opportunity has arisen for a Regulatory Information Administrator to join a leading global healthcare organisation through a Functional Service Provider (FSP) model. Supporting the EMEA MedTech business, this role combines Regulatory Affairs, data management, and project coordination responsibilities within a highly collaborative regional team.

The successful candidate will support the management of regulatory information and actions within a centralised regulatory information management system, ensuring regulatory activities are accurately tracked, maintained, and executed across EMEA markets. This is an excellent opportunity for a junior Regulatory Affairs professional looking to develop their expertise within a global Medical Technology environment.

The role focuses on regulatory data administration and process execution rather than the scientific or technical evaluation of regulatory content. Candidates with strong attention to detail, system proficiency, and an interest in regulatory operations will be particularly well suited.

Key Responsibilities

• Perform Regulatory Impact Assessments using established decision matrices and existing regulatory data repositories.
• Create, update, manage, and close Regulatory Affairs actions within the Regulatory Information Management system.
• Monitor and coordinate regulatory actions across EMEA countries to support regulatory submissions and compliance activities.
• Support country teams by maintaining regulatory records, reports, trackers, and system updates.
• Ensure data accuracy, consistency, and integrity across regulatory databases and information management systems.
• Extract, review, and process information received through internal systems, databases, and email communications.
• Follow established processes and workflows to execute regulatory actions within system-based environments.
• Generate reports and support regulatory data analysis activities.
• Participate in continuous improvement initiatives related to regulatory information management processes.
• Contribute to the development and enhancement of centralised regulatory database systems and reporting tools.
• Provide administrative and operational support to the wider Regulatory Affairs team.

Required Qualifications & Experience

• Previous experience within Regulatory Affairs, Regulatory Operations, Regulatory Information Management, or a related regulated environment.
• Experience working with databases, data management systems, or information administration processes.
• Strong attention to detail and ability to work accurately with large volumes of data.
• Experience maintaining trackers, reports, and structured datasets.
• Strong Microsoft Excel skills, including Pivot Tables and data analysis functions.
• Excellent organisational and coordination skills.
• Ability to manage multiple priorities and follow established processes.
• Strong communication skills and professional proficiency in English (written and verbal).
• Ability to work effectively within cross-functional and international teams.

Preferred Experience

• Experience within the Medical Device industry.
• Familiarity with Regulatory Information Management (RIM) systems or similar regulatory databases.
• Exposure to EMEA Regulatory Affairs processes and regulatory operations.
• Experience supporting international or regional regulatory teams.
• Understanding of project coordination, tracking, or PMO-related activities.

Working Arrangement

• Hybrid role based in either Barcelona or Madrid.
• Combination of office-based and remote working.
• Collaboration with regional EMEA stakeholders and Regulatory Affairs teams.
• Opportunity to work within a highly visible and internationally focused MedTech function.

What's on Offer

• 12-month fixed-term contract with strong likelihood of extension.
• Opportunity to gain experience within a globally recognised healthcare and MedTech environment.
• Exposure to EMEA-wide regulatory operations and information management activities.
• Collaborative and supportive team environment within an established FSP model.
• Excellent opportunity for a junior Regulatory Affairs professional to develop regulatory systems, operations, and data management expertise.