APAC Regulatory Affairs Specialist — Impactful Med Devices

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

Job summary

A leading medical technology company in Malaysia is looking for a Regulatory Affairs Specialist to ensure compliance with APAC and global regulations. This role involves maintaining regulatory knowledge, developing strategy plans, and preparing submissions for regulatory agencies. Ideal candidates should hold a bachelor's degree and have 3-5 years of experience in regulatory affairs within the healthcare or medical device industry. Join us to help improve outcomes for underserved patients and make a meaningful impact.

Qualifications

• 3 to 5 years of regulatory affairs experience, preferably in healthcare or medical device industry.

Responsibilities

• Maintain working knowledge of APAC medical regulations and FDA guidelines.
• Participate in cross-functional product core teams to ensure compliance.
• Develop and document regulatory strategy plans aligned with product development objectives.

Skills

Strong organizational and time-management skills

Ability to work independently and collaboratively

Detail-oriented, responsible, proactive

Strong written and verbal communication skills

Education

Bachelor's degree in a relevant field

Job description

A leading medical technology company in Malaysia is looking for a Regulatory Affairs Specialist to ensure compliance with APAC and global regulations. This role involves maintaining regulatory knowledge, developing strategy plans, and preparing submissions for regulatory agencies. Ideal candidates should hold a bachelor's degree and have 3-5 years of experience in regulatory affairs within the healthcare or medical device industry. Join us to help improve outcomes for underserved patients and make a meaningful impact.