Regulatory Affairs Manager (Medical Devices Company)

REGULATORY AFFAIRS MANAGER - MEDICAL DEVICES COMPANY Salary: Competitive and based on experience Location: Hanoi Keywords: Regulatory Affairs, Medical Device Industry, Vietnam, Product Registrations, Regulatory Compliance

Our client is seeking a Regulatory Affairs Manager to join their team in Hanoi. This role offers an exciting opportunity to ensure market access and continuity by executing product registrations and maintaining regulatory compliance within the medical device industry in Vietnam.

What you'll do:

As a Regulatory Affairs Manager, your will:

* Ensure regulatory compliance in Vietnam
* Compile registration dossiers for new product registrations or change notifications according to regulatory plan and local requirements
* Submit product registrations or change notifications to relevant authorities and obtain approval timely
* Report Field Safety Corrective Actions and Adverse Events to the regulatory authority
* Assess impact of changes initiated by Product Owner and collaborate with supply chain, manufacturing, and commercial teams to ensure no disruption to supply
* Review promotional materials in accordance with local advertising code and guidelines
* Maintain regulatory databases or systems
* Develop regulatory strategy for new product development projects

What you bring:

* Bachelor’s degree in any engineering or science related discipline
* At least 3-5 years’ RA experience in the medical device industry
* Detailed knowledge of the regulatory controls of medical devices in Vietnam
* Highly effective interpersonal skills and ability to build relationships with internal and external stakeholders
* Experience working with diverse cultures
* Excellent written and verbal communication skills in both Vietnamese and English
* Keen learning attitude
* Meticulous attention to detail
* Ability to work independently

What sets this company apart:

Our client is a global leader in their field, committed to improving people's lives through advanced medical solutions. They foster an inclusive and diverse work environment, where every employee is valued for their unique contributions. They offer comprehensive training opportunities to ensure their employees are equipped with the latest industry knowledge and skills.

What's next:

Ready to take the next step in your career? Don't miss this exciting opportunity!

Apply today by clicking on the link. We look forward to receiving your application!

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