Healthcare | Regulatory Affairs Specialist

THE ROLE
The Regulatory Affairs Specialist, Malaysia is a member of the local Regulatory Affairs department, responsible for actively contributing to the regulatory compliance of medical devices under their responsibility. The position is responsible for providing input into the global regulatory strategy and identifying Malaysia requirements for successful regulatory filings for new products/indications.

JOB DETAILS

Position: Regulatory Affairs Specialist

Company: Healthcare

Working Duration: Contract with PERSOLKELLY until December 2025

Working Address: The Pinnacle, Persiaran Lagoon, Bandar Sunway, 46150 Petaling Jaya, Selangor

Working Days/Hours: Monday – Friday: 0830AM to 1730PM

Salary: Basic range from RM3,000– RM4,500 (Based on experience + skills) with statutory contribution + leave entitlement + medical coverage

WHO CAN APPLY?

• A bachelor’s degree, preferably in Pharmacy, Life Science or any related discipline;
• Familiarity with the regulatory systems and product registration requirements in Malaysia;
• Previous experience in preparing documents for health authority submissions is desirable;
• Excellent verbal and written communication skills – proficiency in written and oral English is required;
• Ability to interpret complex issues and technologies and present them in simple terms to facilitate understanding by others;
• Demonstrated ability to handle multiple projects;
• Must be able to develop and maintain excellent working relationships, work successfully within a team environment and as an individual contributor;
• Cultural sensitivity and ability to work and thrive in a multi-cultural environment, as well as an ability to work in a matrix environment are required;
• Enthusiasm for Regulatory Affairs: achievement-oriented with a high degree of flexibility and ability to adapt to a changing regulatory environment;
• Proactive team player, able to take charge and follow-through.

HOW TO APPLY?

Interested candidates for the position are encouraged to send their resumes to Persolkelly at the following email address : [email protected]

#CWSA

Job Types: Full-time, Contract
Contract length: 11 months

Pay: RM3,000.00 - RM4,500.00 per month

Benefits:

• Health insurance
• Maternity leave
• Parental leave
• Professional development

Schedule:

• Monday to Friday

Supplemental Pay:

• 13th month salary
• Performance bonus

Application Question(s):

• How soon you can start work?
• Reason for leaving your current job
• Have experience in preparing documents for health authority submissions ?

Education:

• Bachelor's (Preferred)

Experience:

• Regulatory Affairs: 1 year (Preferred)

Location:

• Petaling Jaya (Preferred)