Regulatory Affairs Senior Executive, Medical Devices

PCCS Group Berhad; Kuala Lumpur; On-site; MYR 200,000 - 250,000; Full time

Job summary

A leading Medical Device company in Kuala Lumpur seeks a Regulatory Affairs Executive to manage regulatory submissions, maintain compliance documentation, and support training sessions. The ideal candidate holds a Bachelor's Degree in Biomedical Science or related field, has 2-5 years of regulatory experience, and is proficient in Microsoft Office. Strong analytical skills and Mandarin proficiency are required for effective communication with partners. This role offers an opportunity to work in a dynamic regulatory environment.

Qualifications

• Minimum 2–5 years of experience in regulatory affairs in medical devices.
• Strong analytical and problem-solving skills.
• Mandarin speaking required for liaising with partners.

Responsibilities

• Oversee regulatory submissions ensuring compliance.
• Prepare and maintain regulatory documentation.
• Support training sessions related to regulatory topics.

Skills

Regulatory affairs experience

Proficient in Microsoft Office

Analytical skills

Team player

Communication skills

Education

Bachelor’s Degree in Biomedical Science or related field

Job description

A leading Medical Device company in Kuala Lumpur seeks a Regulatory Affairs Executive to manage regulatory submissions, maintain compliance documentation, and support training sessions. The ideal candidate holds a Bachelor's Degree in Biomedical Science or related field, has 2-5 years of regulatory experience, and is proficient in Microsoft Office. Strong analytical skills and Mandarin proficiency are required for effective communication with partners. This role offers an opportunity to work in a dynamic regulatory environment.