Manager - Regulatory Affairs | Leading Pharma MNC

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

Job summary

Hindco Recruitment Consultants Bengaluru is seeking an experienced Regulatory Affairs professional to drive compliance for pharma and medical devices, with focus on SaMD and implants.

You will manage MDR 2017 adherence, prepare core technical docs, and coordinate CDSCO submissions, liaising with authorities to secure safe market access.

The role requires 5+ years in regulatory affairs and a strong grasp of India, EU, and US medical device regulations, with B.Pharm or M.Pharm.

Qualifications

• Minimum 5+ years of pharma/regulatory experience.
• Strong knowledge 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 docs.
• Track regulatory updates and coordinate with QA/R&D for safe market access.

Skills

Regulatory compliance

Regulatory submissions

Authority liaison

Technical documentation

QA/R&D collaboration

Regulatory updates tracking

Education

B.Pharm or 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.