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:
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