Executive - Regulatory Affairs | Leading Pharma MNC

Hindco Recruitment Consultants; Mumbai; On-site; INR 1,500,000 - 2,100,000; Full time

Job summary

Hindco Recruitment Consultants seeks an experienced regulatory affairs professional in Mumbai to ensure compliance with MDR 2017 and global regulations. You will manage CDSCO submissions, liaison with authorities, and maintain core technical docs for SaMD and implants.

The role requires 5+ years in pharma, with strong knowledge of medical device regulations (India, EU, US) and a plus for SaMD regulatory experience.

Qualifications

• 5+ years of experience in Pharma with regulatory exposure
• Strong understanding of medical device regulations (India, EU, US)
• Knowledge of SaMD regulations is a plus

Responsibilities

• Ensure compliance with MDR 2017 and global regulations
• Manage CDSCO submissions and authority liaison
• Prepare and maintain core technical documents
• Track regulatory updates and enable safe market access for SaMD and implants with QA/R&D teams

Skills

Regulatory affairs

Medical device regulations

Technical documentation

Education

B.Pharm/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.