APAC Regulatory Strategist for Medical Devices

Zoll Medical Corporation; Selangor; On-site; MYR 70,000 - 90,000; Full time

Job summary

A leading medical technologies company located in Malaysia is seeking a Senior Regulatory Affairs Specialist. This role is crucial for ensuring compliance with APAC medical regulations and FDA guidelines. The candidate will prepare technical submissions and maintain regulatory licenses. Ideal candidates possess a university degree and 3 to 5 years of experience in regulatory affairs within the healthcare sector. The position offers a dynamic work environment focused on patient outcomes and innovative medical solutions.

Qualifications

• 3 to 5 years of Regulatory Affairs experience, preferably in healthcare medical devices industry.
• Understanding of APAC medical regulations and global device regulations.
• Strong writing and communication skills.

Responsibilities

• Assist Regulatory Affairs department to implement compliance activities.
• Participate in product core teams to ensure regulatory compliance.
• Prepare technical dossiers for submission to regulatory authorities.

Skills

Proficient in Microsoft Office

Proficient in Adobe Acrobat DC

Able to work independently

Team player

Organised and results-oriented

Education

University Degree

Job description

A leading medical technologies company located in Malaysia is seeking a Senior Regulatory Affairs Specialist. This role is crucial for ensuring compliance with APAC medical regulations and FDA guidelines. The candidate will prepare technical submissions and maintain regulatory licenses. Ideal candidates possess a university degree and 3 to 5 years of experience in regulatory affairs within the healthcare sector. The position offers a dynamic work environment focused on patient outcomes and innovative medical solutions.