Regulatory Affairs Specialist

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

• Duration of the contract: Until Apr 30, 2027
• Hours per week: 40 per week | Contract: Employed contractor Payroll only (No B2B / No Freelancers)

Imagine your next project shaping the strategic implementation of global regulatory affairs for innovative medical technologies.

Based in the European HQ in Belgium, the Regulatory Affairs Strategy Specialist reports and works under the close supervision of the Manager, Global Strategy & Implementation, CSS. In this role, you will assist and support the CSS Regulatory Affairs Global Strategic Implementation Department in the execution of critical regulatory activities and organizational tasks.

roles and responsibilities

In this role, you will ensure compliance with regulations to enable products to meet regulatory agency requirements and support key commercialization projects.

This will involve:

• Assists by providing knowledge in implementing compliance with regulations to enable products that are developed, manufactured, or distributed to meet regulatory agency requirements.
• Contributes to cross-functional project teams in the development of compliant policies and operational plans to ensure timely commercialization of new and modified products into key markets.
• Coordinates Regulatory Affairs interpretation and feedback in support of regulations by preparing documentation and reports to support internal and external audits.
• Provides operational support for affiliates requests to register products internationally (e.g., conducts submissions for Certificate of Free Sales, organizes manufacturer partnerships, assists with regulatory agency responses, and manages databases).
• Performs Authorized Representative, Importer verification of Manufacturer’s compliance.
• Fulfills products distribution requests in accordance with Regulatory compliance status.
• Assesses, plans and coordinates the execution of product labeling customization activities.
• Acts as back-up for organizational tasks for the CSS Regulatory Affairs Global Strategic Implementation Department (administers SOP updates, supports department POs via Ariba, and acts as Records Management Coordinator).
• Assists in the development of best practices for Regulatory Affairs processes.

how to succeed

You are a meticulous, highly organized professional with excellent communication skills and a desire to continuously learn and improve.

You will also bring:

• 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.

This role offers a very competitive hourly rate. This contract will run until Apr 30, 2027.

you are welcome here

Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about Johnson & Johnson

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. As a skilled contractor, you’ll play a key part in the thinking, strategy, dynamism - and impact - of this iconic global healthcare company as they touch the lives of nearly a billion people every day. Contribute to the next healthcare breakthrough with your next project at Johnson & Johnson.

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means "You Belong".