Quality and Regulatory Executive

Truevis; India; Sur place; INR 400 000 - 700 000; Plein temps

Résumé du poste

Truevis is seeking a Quality and Regulatory Executive/Manager in India to oversee regulatory submissions, documentation, and quality processes. The role reports to the Head - Customer Service & QARA and requires coordinating with consultants and regulatory bodies.

Responsibilities include CDSCO and AERB documentation, new product applications, and incident management, radiation equipment and waste handling. A strong regulatory background and analytical mindset are essential.

Qualifications

• Minimum 2-3 years of regulatory/quality experience.
• Familiarity with CDSCO and AERB guidelines.
• Experience with documentation, submissions, and audits.
• Strong analytical and communication skills.
• Ability to work in a high-risk environment with attention to detail.

Responsabilités

• Prepare, consolidate, and coordinate regulatory documentation for CDSCO and AERB; assist with new product applications.
• Emergency preparedness, incident management, radiation equipment and waste management.

Connaissances

Regulatory compliance

CDSCO knowledge

AERB knowledge

Quality management

Formation

Regulatory affairs certification

Outils

ISO Certification

Description du poste

Job Description : Regulatory and compliance

Job Title : Quality and Regulatory Executive/Manager

Reports to Title : Head - Customer Service & QARA

Key Responsibilities:

• Regulatory CDSCO and AERB all documentation preparation, creations consolidation and coordination with consultant and regulatory bodies . Applications submission for new products and followup of applications submitted
• Emergency Preparedness & Incident Management, Radiation Equipment & Waste Management

Qualifications & Experience:

• Educational Qualification:
• Certification: Regulatory CDSCO, AERB , ISO , Quality preferred
• Experience: Minimum 2-3 years of experience
• Knowledge: Familiarity with Regulatory matters & Quality management
• Strong Technical domain knowledge of subject matter and qualifications .
• Excellent analytical and problem-solving skills.
• Awarenessof CDSCO and AERB guidelines
• Effective communication and training abilities.
• Ability to work in a high-risk environment with attention to detail.
• Strong organizational cross functional and documentation skills.