Regulatory Affairs Specialist (Medical Devices)

TL;DR

Regulatory Affairs Specialist (Medical Devices): Supporting the registration and regulatory compliance of medical devices and biocides with an accent on dossier preparation, submission, and local authority coordination. Focus on maintaining internal processes, artwork development, and cross-functional support for tender and importation activities.

Location: Onsite in Hanoi, Vietnam

Company

hirify.global is a global leader in healthcare, dedicated to protecting and improving the health of people worldwide through innovation, efficiency, and sustainability.

What you will do

• Prepare and submit registration dossiers for medical devices and biocides to local health authorities.
• Monitor and implement updates to local regulations and internal registration processes.
• Coordinate with marketing and supply chain departments to ensure smooth product importation and tender support.
• Manage artwork development processes following product registration approvals.
• Maintain strong relationships with regulatory authorities to facilitate efficient evaluation activities.

Requirements

• Bachelor’s degree in Pharmacy or Chemistry required.
• Fresh graduate or up to 1 year of relevant experience.
• Strong understanding of regulatory registration requirements for medical devices and medicinal products.
• Proficiency in English (verbal and written) is required.
• Strong attention to detail and ability to manage multiple priorities simultaneously.
• Proficiency in Microsoft Office software.

Culture & Benefits

• Opportunity to contribute to a global healthcare mission.
• Professional development within a large, international corporate environment.
• Collaborative team culture focused on transparency and appreciation.