Manager - Regulatory Affairs | Leading Pharma MNC

Hindco Recruitment Consultants; Hyderabad; On-site; INR 1,800,000 - 2,800,000; Full time

Job summary

Hindco Recruitment Consultants seeks a Regulatory Affairs specialist to oversee MDR 2017 compliance and global regulatory activities for medical devices and SaMD in India.

You will manage CDSCO submissions, liaise with authorities, and prepare core technical documentation, while tracking regulatory updates and collaborating with QA/R&D to enable safe market access for implants and SaMD.

Qualifications

• B.Pharm/M.Pharm with 5+ years of experience in pharma regulatory affairs.
• Strong understanding of medical device regulations (India, EU, US).
• Knowledge of Medical Device Software (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 & implants.

Skills

Regulatory understanding

SaMD regulations knowledge

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.