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

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

- Valuable 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

📌 Quality Regulatory Operations Specialist (Bengaluru)
🏢 Nameless
📍 Bengaluru