Regulatory Affairs Specialist (Medical Device-APAC)

Randstad Malaysia; Kuala Lumpur; On-site; MYR 60,000 - 90,000; Full time

Job summary

A leading MNC in medical devices is seeking a Regulatory Affairs Specialist in Kuala Lumpur. The role involves regulatory submissions and ensuring compliance with APAC regulations. Candidates should have a relevant degree and an interest in regulatory affairs, with strong multitasking abilities.

Benefits

Excellent employee compensation and benefits

Qualifications

• Degree in engineering or life sciences preferred; other relevant degrees will be considered.
• Demonstrated interest in regulatory affairs and quality management.
• Strong multitasking skills and ability to manage several projects simultaneously.

Responsibilities

• Prepare and support regulatory submissions of medical devices to health authorities.
• Monitor new or updated regulations impacting product registration.
• Support internal teams with regulatory guidance and maintain product registration processes.

Education

Bachelor Degree

Job description

We are currently looking for a Regulatory Affairs Specialist for one of a Medical Device MNC that specialises with surgical equipment. This position requires your urgent attention.

• Reporting to: Regional RA Manager
• Location: Kuala Lumpur
• Excellent employee compensation and benefits
• Work Type: On-site

the role

• Prepare and support regulatory submissions of medical devices to health authorities, including assisting local partners.
• Monitor and implement new or updated regulations impacting product registration and ensure regulatory databases are current.
• Support internal teams (Sales, Operations, R&D) with regulatory guidance, maintain product registration processes, and participate in quality audits.
• Manage medical device licenses, handle Field Service Notices with authorities, and ensure relevant standards are maintained and updated

the experience

• Degree in engineering or life sciences preferred; other relevant degrees will be considered.
• Demonstrated interest in regulatory affairs and quality management, with experience in APAC regulations being an added advantage.
• Strong multitasking skills and ability to manage several projects simultaneously.

how to apply
Please apply to the job ad above.

skills

no additional skills required

qualifications

no additional qualifications required

education

Bachelor Degree