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