Regulatory Affairs Specialist - Medical devices

A rapidly expanding medical devices company is looking for a Regulatory Affairs Specialist (Manager level) in Ho Chi Minh City to take on a newly created role.

About the Regulatory Affairs Specialist Role:

Reporting to the Head of Regulatory Affairs in headquarter (out of Vietnam), you will be responsible for regulatory procedures and legislation of company's product portfolio.

Key Responsibilities:

• Stay abreast of changes in regulatory procedures and legislation, ensure enforcement of such changes and keep the management updated accordingly
• Develop regulation transition strategy for marketing team to maintain continuous supply of medical device
• Collect, compile and maintain regulatory files, such as CSDT, and ensure maintenance of registrations occurs including initial registration, re-registration and change of notification under new regulation for both company in Vietnam and distributors
• Build and manage regulatory affairs database, such as CSDT database, certificate database and etc.
• Assess device related incidents/complaints for medical device reporting requirements. Compile and submit reportable events to relevant regulatory authorities in timely manner
• Support external regulatory agency audits, providing regulatory input to minimise findings of non-compliance. Coordinate and assist in preparing response to regulatory authorities’ queries within stipulated timelines
• Work closely with the company appointed consultants, identify the rationality of request and build local regulatory platform

To succeed in this role, you must have good communication skills in English.

Key Requirements:

• Major in electronics, automation engineering and biomedical engineering will be preferable
• Working experience in medical device registration will be preferable
• Excellent communication skills with team work spirit; ability to maintain good performance under pressure
• Good communication skill includes English in reading/writing and oral

This firm is a leading global provider of medical devices and solutions that is dedicated to innovation in the fields of patient monitoring & diagnostics imaging system.

If you are talented and have a successful track record of product registration for medical devices and want to take the next step in your career, this is the role for you.

Apply now or call me to discuss this new opportunity.

Due to the high volume of applications we are experiencing, our team will only be in touch with you if your application is shortlisted.