APAC Medical Device Regulatory Specialist

Flexicare Group; Kuala Lumpur; On-site; MYR 60,000 - 90,000; Full time

Job summary

A leading medical device company in Kuala Lumpur is seeking a Regulatory Specialist to manage submissions and ensure compliance with regulations in the APAC region. The ideal candidate must have 2-3 years of experience in Regulatory Affairs, a Bachelor's degree in Science, and excellent communication skills in English. Knowledge of ISO standards and multiple languages is a plus. This position offers the opportunity to work independently and help navigate complex regulatory requirements while collaborating with cross-functional teams.

Qualifications

• Minimum 2-3 years of experience in Regulatory Affairs for medical devices.
• Excellent verbal and written communication skills.
• Strong ability to manage multiple projects independently.
• Comprehensive understanding of regulatory activities.

Responsibilities

• Support submissions of registrations and licenses in APAC.
• Compile technical files for EU MDR to obtain CE marking.
• Collaborate with teams to ensure regulatory compliance.
• Stay updated on regulations and communicate impacts.

Skills

Regulatory Affairs experience

Strong English proficiency

Knowledge of multiple languages

ISO13485 knowledge

Computer skills

Attention to detail

Problem-solving ability

Education

Bachelor’s Degree in Science

Tools

Microsoft Office

Windows

Job description

A leading medical device company in Kuala Lumpur is seeking a Regulatory Specialist to manage submissions and ensure compliance with regulations in the APAC region. The ideal candidate must have 2-3 years of experience in Regulatory Affairs, a Bachelor's degree in Science, and excellent communication skills in English. Knowledge of ISO standards and multiple languages is a plus. This position offers the opportunity to work independently and help navigate complex regulatory requirements while collaborating with cross-functional teams.