Medical Device Regulatory Specialist – CE/MDR & APAC Expert

Flexicare Group; Kuala Lumpur; On-site; MYR 70,000 - 100,000; Full time

Job summary

A healthcare solutions provider is looking for a Regulatory Affairs professional based in Kuala Lumpur. You will manage submissions, certifications, and compliance for medical devices across the APAC region, collaborating with various teams and ensuring adherence to standards. The ideal candidate should have a Bachelor's in Science, 2-3 years of experience in Regulatory Affairs, and exceptional communication skills. This position requires flexibility in working hours for coordination with the UK office.

Qualifications

• Minimum 2 - 3 years work experience in Regulatory Affairs for medical device products.
• Excellent verbal and written communication skills with strong English language proficiency.
• Comprehensive understanding of regulatory activities.

Responsibilities

• Support submissions of registrations, licenses, and renewals in APAC region.
• Compile and review technical file for EU MDR to obtain/maintain CE marking.
• Collaborate with cross-functional teams to ensure regulatory compliance.

Skills

Regulatory Affairs experience

Communication skills

Attention to detail

Problem-solving

Knowledge of ISO standards

Team collaboration

Education

Bachelor's Degree in Science

Tools

Microsoft Office

Windows

Job description

A healthcare solutions provider is looking for a Regulatory Affairs professional based in Kuala Lumpur. You will manage submissions, certifications, and compliance for medical devices across the APAC region, collaborating with various teams and ensuring adherence to standards. The ideal candidate should have a Bachelor's in Science, 2-3 years of experience in Regulatory Affairs, and exceptional communication skills. This position requires flexibility in working hours for coordination with the UK office.