Executive - Regulatory Affairs | Leading Pharma MNC

Hindco Recruitment Consultants; Indore District; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Hindco Recruitment Consultants seeks an experienced Regulatory Affairs professional with 5+ years in pharma and medical devices. You will ensure MDR 2017 compliance and manage CDSCO submissions, liaising with authorities to secure approval for SaMD and implant products.

The role requires strong understanding of India, EU, and US regulations, with knowledge of SaMD regulations as a plus. Collaboration with QA/R&D is essential to maintain safe market access and regulatory readiness.

Qualifications

• B.Pharm or M.Pharm with 5+ years of pharma/regulatory experience.
• 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

MDR 2017

CDSCO submissions

Regulatory liaison

SaMD regulations

QA/R&D coordination

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.