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