We are looking for a detail-oriented Regulatory Compliance Associate to support our Quality Management System, regulatory compliance, documentation, audits, and medical device regulatory activities.

? Key Responsibilities

- Maintain and implement the Quality Management System (QMS)
- Prepare, review and control SOPs, quality records and documentation
- Monitor manufacturing processes for compliance with approved procedures
- Conduct/support internal, supplier and external audits
- Ensure compliance with ISO 13485 and applicable medical device standards
- Coordinate with Production, QC, Ramp and Service teams on quality issues
- Support process validation, product quality checks and improvement activities
- Maintain product traceability and regulatory documentation
- Support CDSCO,



licensing and regulatory compliance activities
- Maintain product registrations, licenses, certificates and approvals

? Key Requirements
- Bachelors/Masters degree in B.Pharm, M.Pharm, Biomedical Engineering (Preferred), Biotechnology or related field
- Minimum 2 years of relevant experience
- Knowledge of ISO 13485, QMS and medical device manufacturing preferred
- Strong documentation, analytical and problem-solving skills
- Excellent attention to detail
- Positive command over MS Office and relevant technical tools

📌 Regulatory Compliance Associate (Raipur)
🏢 VENSI
📍 Raipur