Regulatory Affairs Intern

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

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Job Description:

Johnson & Johnson is currently recruiting for a Regulatory Affairs Intern, located in Petaling Jaya, Malaysia. The intern must be able to commit for at least 3 months.

This internship program provides foundational, hands-on exposure to regulatory activities within the medical devices industry. The interns will gain a basic understanding of local regulatory requirements, and practical experience in pre-market submission documentation and regulatory database management.

Key Responsibility:

• Support the Regulatory Affairs team in targeted activities across the product license lifecycle.

• Review and compile pre-market documentation for new product registrations, re-registrations, change notifications, and other regulatory submission types.

• Assist with pre-market regulatory submissions and tracking of pre‑market submissions until acceptance, including responding to health authority queries under supervision.

• Support regulatory database management and maintenance.

Learning outcome:

Upon completion of the program, the intern will be able to:

• Understand the key requirement of the Malaysia Medical Device Act and Regulations.

• Gain an overall understanding of the product regulatory lifecycle and identify regulatory milestones for market entry into Malaysia.

• Explain the role of Regulatory Affairs and its impact in the Medical Device industry.

• Prepare pre‑market submission and compile dossier according to the accepted best practices.

• Apply regulatory database management practices in line with RA SOP and quality management system.

• Gain exposure to a diverse range of medical device types and classifications.

• Operate effectively within a GDPMD‑certified, high‑compliance environment to observe and adopt regulatory best practices.

Preferred Skills & Qualifications

• Currently enrolled in a relevant degree program (e.g., Engineering, Science, Pharmacy, or equivalent) at an accredited Malaysia university

• Strong attention to detail and a methodical approach to data handling and documentation.

• Strong analytical and comprehension skills.

• Excellent verbal and written communication skills; proficiency in English is required.

• Familiarity with productivity tools (Excel, Teams, SharePoint)

• Interest in digital tools (Power BI, PowerApps)

• Eager to learn, collaborative team player, and self-motivated.

• Able to work effectively in a matrixed, fast-paced environment.

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