Specialist, Commercial Quality & Regulatory Affairs

Location: On-site in Taipei, Taiwan, supporting regulatory affairs for Taiwan and Hong Kong.

Company

hirify.global develops life sciences, diagnostics, and biotechnology solutions, including precision diagnostic products.

What you will do

• Interpret Taiwan and Hong Kong regulations applicable to medical device and IVD products and advise on compliance impact.
• Support regulatory submissions, filings, renewals, post-approval changes, licenses, certificates, and market approvals.
• Maintain and execute commercial quality management system processes, including investigations, deviations, complaints, and corrective actions.
• Support interactions with health authorities, audits, inspections, and responses to regulatory questions.
• Prepare quality metrics and management reports, maintain regulatory files, and track obligations in regulatory databases.
• Collaborate with regulatory affairs, quality, supply chain, and commercial teams.

Requirements

• Bachelor’s degree in science, pharmacy, engineering, or a related field; alternatively, a relevant master’s degree.
• At least 3 years of experience, or 2 years with a master’s degree.
• Familiarity with ISO 13485 quality systems and regulatory affairs principles.
• Regulatory or scientific knowledge applicable to the medical device or IVD industry in Taiwan or Hong Kong.
• Strong technical writing, attention to detail, project management, and cross-functional collaboration skills.

Culture & Benefits

• Participation in the APAC Commercial Quality and Regulatory Affairs team.
• Continuous improvement through the hirify.global Business System.
• Comprehensive benefits, including healthcare programs and paid time off.
• Work focused on improving access to precise diagnostic results and treatment options.