Executive - Regulatory Affairs | Leading Pharma MNC

Hindco Recruitment Consultants; Bengaluru; On-site; INR 1,500,000 - 2,200,000; Full time

Job summary

Hindco Recruitment Consultants seeks a regulatory affairs specialist with pharma and medical device experience to ensure MDR 2017 compliance and manage CDSCO submissions for SaMD and implants.

You will liaise with authorities, maintain core technical docs, and track regulatory updates while collaborating with QA/R&D to facilitate safe market access.

Qualifications

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

Regulatory knowledge

SaMD regulations

Global 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.