(Senior) RA Specialist

Location: Hong Kong, HK; site-based with 0 days working from home

Company

hirify.global provides medical technology and solutions for hospitals and life science institutions, supporting intensive care, cardiovascular procedures, operating rooms, sterile reprocessing, and life science.

What you will do

• Develop and implement regulatory strategies for assigned medical device projects with global and local teams.
• Prepare, coordinate, and submit product registration applications to local health authorities.
• Review product change assessments and take actions to maintain regulatory compliance and business continuity.
• Provide stakeholders with updates on registration progress and regulatory trends affecting products.
• Maintain submission dossiers, product licenses, and regulatory communications.
• Support SSU QRC activities, including internal and external audits.

Requirements

• Bachelor’s degree or higher in Biomedical Engineering, Medical Sciences, Biotechnology, or a related science or engineering field.
• 2–4 years of experience in product registration or QMS within the medical device industry.
• Proven experience with regulatory submissions in Hong Kong, including new listings and product changes.
• Strong understanding of medical device regulations and requirements in Hong Kong and Macao.
• Basic understanding of, or willingness to learn, medical device registration processes and QMS requirements supporting ISO 13485 and ISO 9001 compliance.
• Good written and spoken English and Chinese are required. Cantonese is preferred.

Nice to have

• Previous experience working in a multinational company.
• Cantonese language skills.

Culture & Benefits

• Work with diverse teams focused on making life-saving technology more accessible.
• Opportunities for personal and professional development.
• Reasonable accommodations are available during the selection process upon request.