Global Regulatory Affairs Strategist — Contract

Johnson & Johnson; Brussel; Sur place; EUR 55 000 - 96 000; Plein temps

Résumé du poste

Johnson & Johnson is seeking a Regulatory Affairs Strategy Specialist based in Belgium to support the Global Strategic Implementation Department. The role involves regulatory activities, cross-functional collaboration, and coordination of submissions for international markets.

You will assist in developing compliant policies, organizing documentation, and ensuring regulatory alignment for new and modified products across markets. A strong focus on accuracy and communication is expected.

Qualifications

• 1-2 years of work experience in Regulatory Affairs or Quality preferred. Candidates with <2 years of practical experience who currently possess an advanced degree will also be considered.
• University/Bachelors Degree or Equivalent.
• Excellent written and verbal communications skills in English.
• Creative and good computer skills: Pack Office, Outlook, OneNote, TEAMS.
• Ability to execute with attention to details, meticulousness, and applying Good Documentation Practices.
• Ability to take on diverse tasks; executes under direction of an expert and offers insight.
• Ability to work in and with a diverse team.
• Desire to learn and continuously improve.
• Good organizational skills, project management methodology is a plus.
• Preferred: knowledge of medical device regulatory requirements in the EU, Quality Management Systems and experience in the Medical Device industry or medical field.

Responsabilités

• Assists by ensuring compliance with regulations to enable products to meet regulatory agency requirements.
• Contributes to cross-functional project teams in developing compliant policies and operational plans for timely commercialization.
• Coordinates Regulatory Affairs interpretation and feedback to support regulatory submissions and audits.
• Provides operational support for affiliates by registering products internationally and managing related documentation.
• Performs Authorized Representative and Importer verification of Manufacturer’s compliance.
• Fulfills product distribution requests in accordance with Regulatory compliance status.
• Plans and coordinates product labeling customization activities.
• Assists in SOP updates and supports department purchase orders via Ariba.
• Develops best practices for Regulatory Affairs processes.

Connaissances

Regulatory Affairs knowledge

Quality management

English communication

Formation

Bachelor's degree

Outils

Microsoft Office

Outlook

OneNote

Teams

Description du poste

Johnson & Johnson is seeking a Regulatory Affairs Strategy Specialist based in Belgium to support the Global Strategic Implementation Department. The role involves regulatory activities, cross-functional collaboration, and coordination of submissions for international markets.

You will assist in developing compliant policies, organizing documentation, and ensuring regulatory alignment for new and modified products across markets. A strong focus on accuracy and communication is expected.