Senior RA Specialist (Medtech)

Location: Onsite in Hong Kong

Company

hirify.global provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows across intensive care, cardiovascular procedures, and sterile reprocessing.

What you will do

• Develop and implement regulatory strategies for assigned projects in collaboration with global and local teams.
• Prepare, coordinate, and submit regulatory applications to local health authorities to ensure timely approvals.
• Review product change assessment requests to ensure regulatory compliance and business continuity.
• Provide regular updates to internal stakeholders on registration progress and regulatory trends.
• Maintain and organize regulatory records, including submission dossiers and product licenses.
• Support SSU QRC activities, including internal and external audits.

Requirements

• Bachelor’s degree or above in Biomedical Engineering, Medical Sciences, Biotechnology, or a related field.
• 2-4 years of experience in product registration or QMS within the medical device industry.
• Proven track record of successful regulatory submissions in Hong Kong.
• Solid understanding of medical device regulations in Hong Kong and Macao markets.
• Must be based in Hong Kong.
• Good command of written and spoken English and Chinese.

Nice to have

• Previous work experience in a Multinational Corporation (MNC).
• Proficiency in Cantonese.
• Knowledge of ISO 13485 and ISO 9001 requirements.

Culture & Benefits

• Opportunity to work in a diverse team of passionate people.
• Career paths that allow for both personal and professional development.
• Mission-driven environment focused on making life-saving technology accessible.