Regulatory Affairs Intern

Petaling Jaya - Malaysia

Monthly Salary: Not Disclosed

Posted on: 2 days ago

Vacancies: 1 Vacancy

Job Summary

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

Job Function:

Career Programs

Job Sub Function:

Non-LDP Intern/Co-Op

Job Category:

Career Program

All Job Posting Locations:

Petaling Jaya Selangor Malaysia

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 premarket 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 premarket 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 GDPMDcertified highcompliance 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.

Required Skills:

Analytical Thinking Collaboration Learning Agility

Preferred Skills:

Required Experience:

Intern