Principal Officer, Regulatory Affairs (IVD/CDx)

Location: Suzhou, Jiangsu, China

Company

hirify.global partners with customers across the globe to address complex challenges through science and technology solutions.

What you will do

• Submit product registration dossiers and obtain approvals in line with registration plans, regulations, and SOPs.
• Establish and execute CDx registration strategies for China, the US, the EU, and other target markets.
• Lead domestic and overseas registration cases and maintain submission and approval documentation in relevant IT systems.
• Participate in product design and development, including Drug–Diagnostic Reagent co-development projects with pharmaceutical partners.
• Interpret global MD, IVD, and CDx regulatory updates and provide regulatory support to cross-functional teams, dealers, and customers.
• Support GMP and ISO 13485 quality-system development and maintenance, and maintain relationships with NMPA, testing centers, and health authorities.

Requirements

• Bachelor’s degree or above.
• At least 5 years of regulatory affairs experience in the IVD industry.
• Expertise in NMPA IVD and/or medical-device regulations and registration processes.
• Good English and Chinese language skills.
• Strong teamwork, interpersonal communication, accountability, and creative problem-solving skills.
• Relevant background in medicine, bioengineering, clinical medicine, biochemistry, or pharmacy is preferred.

Nice to have

• China CDx initial registration experience.
• US or EU IVD registration experience.

Culture & Benefits

• General office working environment.
• Business travel may be required occasionally.
• Regular collaboration with headquarters, marketing, logistics, application, sales and service, QA, and R&D teams.