Quality Regulatory Operations Specialist

Duties & Responsibilities:

• Support RA/QA operations across JPAC, including maintaining compliance and documentation accuracy

  
  

• Assist with tender support activities, including preparation and review of regulatory and quality documentation

  
  

• Collaborate with Commercial and cross-functional teams to support timely submission of required documentation

  
  

• Support regulatory intelligence activities, including tracking regulatory updates and assisting with impact assessments

  
  

• Maintain and organize regulatory documentation and records in alignment with internal systems and requirements

  
  

• Assist in Quality Management System (QMS) processes (ISO 13485), including CAPA tracking, change control, and audit preparation

  
  

• Support internal and external audits, including documentation collection and coordination

  
  

• Assist with complaint handling, vigilance, and post-market activities, including data tracking and documentation

  
  

• Provide support for field actions and recalls, ensuring documentation and coordination activities are maintained

  
  

• Assist with distributor/importer registrations and compliance activities across JPAC markets

  
  

• Support labeling and claims review activities, ensuring documentation is compliant with regional requirements

  
  

• Utilize regulatory and quality systems (RIM/eQMS) to maintain accurate records and support reporting

  
  

• Contribute to process improvements and standardization initiatives
   

  
  

Minimum & Preferred Qualifications and Experience: