Regulatory Affairs Specialist - Labelling & Submissions

Cochlear; Kuala Lumpur; On-site; MYR 55,000 - 75,000; Full time

Job summary

A leading medical device company in Kuala Lumpur is seeking a Regulatory Affairs Specialist to support regulatory submissions, product registrations, and compliance with international standards. The ideal candidate will have a Bachelor's degree in a related field and 2-3 years of relevant experience. Responsibilities include managing regulatory documentation, ensuring adherence to quality standards, and collaborating with cross-functional teams for successful product launches. This role offers an opportunity to contribute to regulatory strategy and continuous improvement initiatives.

Qualifications

• Bachelor’s degree in science, Biomedical Engineering, or related discipline is required.
• 2-3 years of experience in medical device or pharmaceutical industry, ideally in Regulatory Affairs.
• Good understanding of regulatory submission processes and regulations.

Responsibilities

• Support preparation and maintenance of regulatory submissions and product registrations.
• Assist interpretation and application of medical device labelling standards.
• Compile and submit regulatory files and product license renewals.
• Support review and approval of clinical study documents and advertising materials.
• Identify opportunities for process improvement in compliance and documentation.

Skills

Strong organizational skills

Attention to detail

Excellent written and verbal communication

Analytical abilities

Problem-solving abilities

Team collaboration

Education

Bachelor's degree in science or Biomedical Engineering

Advanced degree or RACS certification

Job description

A leading medical device company in Kuala Lumpur is seeking a Regulatory Affairs Specialist to support regulatory submissions, product registrations, and compliance with international standards. The ideal candidate will have a Bachelor's degree in a related field and 2-3 years of relevant experience. Responsibilities include managing regulatory documentation, ensuring adherence to quality standards, and collaborating with cross-functional teams for successful product launches. This role offers an opportunity to contribute to regulatory strategy and continuous improvement initiatives.