Hemant Surgical Industries Limited
Website:
hemantsurgical.com
Job details:
Company Description
Hemant Surgical Industries Limited, established in 1989 and based in India, specializes in providing high-quality medical products. With over 30 years of experience, the organization represents leading international brands and is recognized as a sole agent for JMS Co. Ltd., Japan, and JMS Singapore Pte Ltd. Renowned for its commitment to excellence, the company has established itself as a trusted name in the medical fraternity, offering innovative and reliable medical solutions. Hemant Surgical Industries continues its dedication to enhancing healthcare through its collaboration with global industry leaders.
Role Description
This is a full-time, on-site role for a Junior Executive – Regulatory Affairs & Compliance at Hemant Surgical Industries Limited, located in Mumbai - Mulund . The role involves preparing and maintaining regulatory documentation, ensuring compliance with regulatory requirements, and supporting dossier preparation. The Junior Executive will collaborate with internal teams and stakeholders to uphold regulatory standards while assisting in compliance-related activities and documentation management.
Junior Executive – Regulatory Affairs & Compliance
For Hemant Surgical Industries Limited
Location: Mumbai
Department: Regulatory Affairs & Compliance
Industry: Medical Devices / Surgical Disposable Manufacturing
Job Summary
We are looking for a Junior Executive – Regulatory Affairs & Compliance for the medical device division. The candidate should have basic knowledge of regulatory requirements, documentation, and quality compliance related to medical devices.
The ideal candidate should have exposure to CDSCO regulations, GMP documentation, BIS standards, and ISO 13485 quality management systems.
Key Responsibilities
- Support regulatory documentation and compliance activities for medical devices.
- Coordinate with internal departments for regulatory submissions and approvals.
- Maintain records related to CDSCO licenses and registrations.
- Assist in implementation and maintenance of ISO 13485 documentation.
- Ensure compliance with GMP guidelines and regulatory standards.
- Support audit preparation and compliance reporting.
- Maintain technical files, SOPs, and quality documents.
- Coordinate with QA/RA team for product compliance activities.
- Follow BIS standards and regulatory updates related to medical devices.
Required Skills
- Knowledge of CDSCO regulations
- Understanding of GMP practices
- Knowledge of BIS standards
- Familiarity with ISO 13485 documentation
- Documentation and reporting skills
- Good communication and coordination skills
- MS Office knowledge
Qualification
- B.Pharm / M.Pharm / B.Sc / M.Sc / Biomedical / Life Science or related field
- Candidates with 1–4 years experience can apply
Preferred Candidate Profile
- Experience in medical devices or pharmaceutical regulatory affairs preferred
- Good understanding of compliance documentation
- Detail-oriented and organized
Salary
As per company standards and candidate experience.
Apply
Send CV to: hr@hemantsurgical.com
Click on Apply to know more.