Regulatory Affairs Executive

Vital; Kuala Lumpur; On-site; MYR 50,000 - 80,000; Full time

Job summary

Vital in Kuala Lumpur is seeking a Regulatory Affairs professional to ensure compliance of medical device products with MDA, CE, and FDA standards. The role involves registration, certification renewals, and close interaction with government bodies to obtain timely approvals.

The ideal candidate has at least 1 year in regulatory affairs within pharma or medical devices, with strong communication and documentation skills, and familiarity with Malaysia’s regulatory landscape.

Qualifications

• Bachelor’s degree in Biomedical Engineering or related field.
• Minimum 1 year of regulatory affairs experience in pharma or medical device industry.
• Excellent understanding of Malaysia regulatory landscape (MDA) and CE regulations.
• Excellent communication and interpersonal skills, able to liaise with internal and external stakeholders.
• Fresh graduates are encouraged to apply.

Responsibilities

• Ensure regulatory compliance of company products and review documentation for MDA, CE, FDA, and other regions.
• Carry out product registration, system certification, renew certificates, and apply for certificate replacement.
• Follow up on registration and internal review, submit information to complete applications.
• Coordinate with government and industry departments to obtain timely registration approvals.
• Stay up-to-date with latest regulatory requirements and guidelines in the medical device industry.
• Liaise with regulatory authorities and stakeholders to address queries and ensure timely approvals.
• Provide regulatory guidance to product development and marketing teams.
• Participate in development of regulatory strategies and policies for company growth.

Skills

Regulatory knowledge

Communication

Stakeholder liaison

Documentation

Education

Bachelor's degree in Biomedical Engineering

Job description

Regulatory Compliance: Ensure regulatory compliance of company products and review documentation of medical device standards of MDA, European Union (CE), USA (FDA), and other regions.

Product Registration & Certification: According to the company’s plan, carry out product registration, system certification, renewal of certificates obtained, and application for certificate replacement.

Registration Submission: Follow up on the registration and internal review of registration application information throughout the process, and submit the application information to complete the registration application and supplementary application-related work.

Registration Follow-up & Coordination: Follow up on product registration progress, communicate with government and relevant industry departments on registration matters, coordinate and resolve issues during the registration process, and ensure that registration approval documents are obtained on time.

Regulatory Updates: Stay up-to-date with the latest regulatory requirements and guidelines in the medical device industry.

Regulatory Authority Liaison: Liaise with regulatory authorities and other stakeholders to address queries and ensure timely approval of our products.

Regulatory Support: Provide regulatory guidance and support to the product development and marketing teams.

Regulatory Strategy: Participate in the development of regulatory strategies and policies to support the company’s growth objectives.

Job Requirement

Education:Bachelor’s degree in Engineering—Biomedical, Medical Science, or a related field.

• Experience: Minimum 1 year of experience in a regulatory affairs role within the pharmaceutical or medical device industry

Regulatory Knowledge: Excellent understanding of the regulatory landscape in Malaysia, including the requirements of the Malaysian Medical Device Authority (MDA) and CE regulations.

Communication Skills: Excellent communication and interpersonal skills, with the ability to liaise effectively with internal and external stakeholders

• Fresh graduates are encouraged to apply!