RAO Specialist (MedTech)

TL;DR

RAO Specialist (MedTech): Managing regulatory documentation and ensuring compliance with medical device regulations and ISO 13485 with an accent on regulatory operations and information management. Focus on maintaining audit-ready records, managing UDI data, and supporting internal and external regulatory inspections.

Location: Shanghai, China (Changning District)

Company

Global provider of products and solutions for hospitals and life science institutions, employing over 12,000 people worldwide.

What you will do

• Manage the archiving and release of regulatory documentation across required computer systems.
• Maintain and update regulatory approvals, labeling data, and UDI information.
• Ensure all regulatory records are complete, accurate, traceable, and audit-ready.
• Support ISO 13485 audits, notified body assessments, and regulatory authority inspections.
• Prepare evidence packages for inspections and support the tracking and closure of CAPAs.
• Collaborate with cross-functional teams on regulatory operations projects and continuous improvement initiatives.

Requirements

• Bachelor's degree in Life Sciences, Biomedical Engineering, Pharmacy, Regulatory Affairs, or data statistical analysis.
• 2+ years of experience in Regulatory Affairs, Regulatory Operations, or Quality Systems within a medical device environment.
• Experience working under an ISO 13485-certified Quality Management System (QMS).
• Fluency in English (written and spoken).
• Must be located in or able to work in Shanghai, China.

Culture & Benefits

• Opportunities for both personal and professional development.
• Diverse and passionate team environment focused on life-saving technology.
• Employment is facilitated via a contract with an external third-party company.