Regulatory Affairs Project Manager China

We are looking for a detail-oriented and proactive professional to ensure effective regulatory compliance and support regulatory submissions and audits in China and the wider Asia Pacific region.

This role supports product regulatory lifecycle activities for the Rayner sales organization.

What Youll Be Doing:

Provide support for registration activity in the assigned geographic region including (but is not limited to):

• Developing registration and launch plans with the regional sales managers.
• Assistance with the preparation and submission of registration dossiers, and their remediation.
• Ensure compliance with local requirements.
• Interface and co-ordinate with regulatory agencies (including at both national and internal-regional level in China); provide regulatory input and appropriate follow-up support to inspections and audits (e.g. NMPA).
• Interpret local and international regulatory guidelines and ensure alignment with company procedures and country specific regulatory requirements.
• Monitor changes in the local regulatory landscape and advise relevant teams on impacts.
• Evaluate proposed product and documentation changes for regulatory impact and ensure timely submission to authorities when required.
• Provide regulatory support for the Rayner quality audit programme.
• Coordinate and support country-specific regulatory inspections and certifications (e.g., import licenses, etc.).
• Work within the global regulatory team to align regional compliance strategies.
• Prepare, support, or lead the preparation of regulatory dossiers for product registrations across the region, coordinating with internal teams to ensure compliance with applicable regulatory requirements, timely submission to relevant government authorities, and proactive follow‑up to address regulatory queries as needed.
• Support and lead local tender and reimbursement applications for devices marketed in the region.
  
  
  

• Bachelor’s degree in Life Sciences, Regulatory Affairs, Business Administration, Finance, or related discipline
• 5 years of relevant experience in regulatory affairs and/or commission management
• Experience with regulatory processes (e.g. licensing, product registration)
• Hands-on experience with commission calculation or incentive program administration
• Experience working with ERP or CRM systems
• Proficiency in Microsoft Office Suite, especially Excel
• Excellent written and verbal communication in English and Mandarin
  
  
  

• Certification or training in Regulatory Affairs