Quality Regulatory Operations Specialist

Job Description

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
  
  

• Bachelor’s degree in Life Sciences, Pharmacy, Biomedical Engineering, or related field
• 2–5 years of experience in Regulatory Affairs and/or Quality Assurance (medical device or healthcare preferred)
• Basic understanding of JPAC regulatory frameworks (e.g., CDSCO, PMDA, TGA, HSA, NMPA)
• Exposure to Quality Management Systems (ISO 13485) and related processes (CAPA, audits, change control)
• Exposure to or interest in regulatory submissions and product lifecycle processes
• Strong attention to detail and organizational skills
• Good analytical and problem-solving abilities
• Strong written and verbal communication skills
• Ability to work effectively in a cross-functional environment
• Familiarity with document management or regulatory systems (RIM/ eQMS ) is a plus