Executive - Regulatory Affairs | Leading Pharma MNC

Hindco Recruitment Consultants; Lucknow; On-site; INR 1,200,000 - 2,000,000; Full time

Job summary

Hindco Recruitment Consultants is seeking an experienced Regulatory Affairs professional to ensure MDR2017 and global regulatory compliance for pharma and medical devices in India.

You will manage CDSCO submissions, liaise with authorities, and maintain core technical documentation. The role requires staying current with regulatory updates and collaborating with QA/R&D to enable safe market access for SaMD and implants.

Qualifications

• B.Pharm/M.Pharm with 5+ years of pharma experience.
• Strong understanding of medical device regulations (India, EU, US).
• Knowledge of SaMD regulations is a plus.

Responsibilities

• Ensures compliance with MDR 2017 and global regulations.
• Manages CDSCO submissions, authority liaison, and core technical docs.
• Tracks regulatory updates; works with QA/R&D to enable safe market access for SaMD and implants.

Skills

Regulatory knowledge

SaMD regulations

Education

B.Pharm or M.Pharm

Job description

• Ensures compliance with MDR 2017 and global regulations.
• Manages CDSCO submissions, authority liaison, and core technical docs.
• Tracks regulatory updates; works with QA/R&D to enable safe market access for SaMD & implants.

Required Candidate profile

• B.Pharm/M.Pharm with 5+ years of experience in Pharma.
• Strong understanding of medical device regulations (India, EU, US).
• Knowledge of Medical Device Software (SaMD) regulations is a plus.