RA Intelligence Officer

Department Info

EMEA Quality, Regulatory & Vigilance Division – Regulatory Affairs.

Job Summary

As a Regulatory Affairs Intelligence Officer, you support the Regulatory Affairs department in monitoring and analysing regulatory developments and ensuring compliance with applicable legislation and standards for medical devices.

In this role, you work closely with the RA Director and RA Intelligence Specialist to provide timely insights on regulatory changes and support the organisation in maintaining compliance across the EMEA region.

Job Responsibilities

Strategic Planning & Execution

• Monitor developments and trends in European regulations for medical devices, including in vitro diagnostics


• Follow regulatory and legal developments at national and international level (EMEA, US, Canada, Australia, China, etc.)


• Support local offices on regulatory matters

Product Lifecycle Management

• Monitor and analyse standardisation activities (ISO, EN, IEC and national standards)


• Support implementation of updated standards and regulations within the organisation


• Assist in impact analyses and implementation strategies for regulatory compliance

Stakeholder & Team Support

• Communicate regulatory and standardisation updates to relevant departments


• Support RA members in daily activities such as registration file preparation, technical file review and product labelling


• Assist in training and onboarding of RA team members on legislation and standards

Performance & Process Improvement

• Maintain and develop databases and systems related to regulatory information


• Contribute to monthly and bi-annual reports on regulatory changes and trends


• Support projects related to regulatory processes and compliance

Compliance & Quality

• Support the organisation in ensuring compliance with applicable regulations and standards


• Follow up on implementation of updated regulatory requirements


• Liaise with national authorities under guidance of senior RA leadership

Profile Description

• University degree in a scientific field, preferably medical or pharmaceutical oriented, or equivalent experience


• Experience in a scientific environment (e.g. clinical research, biochemistry)


• At least 1 year of experience in Regulatory Affairs within medical devices


• Strong interest in analysing legislation and its impact on business

In addition, you recognize yourself in the following:

• Accurate, well-organised and self-disciplined


• Strong team player with excellent communication skills


• Detail-oriented with strong analytical capability


• Able to manage information, projects and regulatory data effectively


• Good command of English; additional languages are an advantage

Offer

You will join an international Regulatory Affairs environment where you play an active role in monitoring regulatory developments, driving their implementation, and helping ensure compliance across the organisation.

Contact Person

Jarne Jans, Talent Acquisition Team