Executive - Regulatory Affairs | Leading Pharma MNC

Hindco Recruitment Consultants; Ernakulam; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Hindco Recruitment Consultants is seeking a regulatory affairs professional with 5+ years of experience in pharma/regulatory operations to ensure MDR 2017 and global regulatory compliance. The role involves managing CDSCO submissions, liaising with authorities, and maintaining core technical documentation for SaMD and implants.

Candidates should have a strong understanding of India/EU/US medical device regulations with a preference for knowledge of SaMD regulations.

Qualifications

• B.Pharm/ M.Pharm with 5+ years of experience in Pharma and regulatory operations.
• 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

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.