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Insurance

Are you looking to excel in the dynamic field of regulatory affairs? This exciting opportunity in New Delhi, India, is perfect for professionals seeking to advance their careers as a Regulatory Affairs Specialist. Here’s everything you need to know about the role, its responsibilities, required qualifications, skills, and the application process.


Company Overview

This leading organization specializes in healthcare innovation and regulatory compliance. With a robust portfolio of products and services, the company is committed to ensuring that medical devices meet the highest standards of safety and efficacy. The New Delhi team is a hub for regulatory excellence, providing professionals with opportunities to collaborate with experts and contribute to cutting-edge projects.


Job Responsibilities

As a Regulatory Affairs Specialist, you will play a pivotal role in ensuring compliance with local and international regulations. Key responsibilities include:

  1. Regulatory Strategy Execution
    • Implement strategies for regulatory approvals as per annual registration plans.
    • Compile and evaluate dossiers for submission in India.
  2. Collaboration and Documentation
    • Work with Business Units to fulfill product approval requirements.
    • Coordinate with the Labeling team to ensure India-specific labels meet regulations.
    • Support sales teams with regulatory documents for tender approvals.
  3. Regulatory Compliance
    • Prepare and submit PSURs, PMS reports, adverse event reports, and other safety documents.
    • Stay updated with the latest medical device regulations in India.
  4. Stakeholder Engagement
    • Network and liaise with central and state regulatory agencies.
    • Assist in field safety corrective actions, recalls, and CAPA activities.
  5. Audit and Quality Support
    • Support internal and external quality and compliance audits.
    • Contribute to the development of SOPs and procedures with international quality teams.

Qualifications

To be considered for this position, candidates should meet the following criteria:

  • A Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or a related field.
  • 3–5 years of experience in regulatory affairs, specifically in medical devices.
  • Knowledge of Indian medical device regulations and global compliance standards.

Key Skills

  • Strong technical knowledge in regulatory dossier preparation.
  • Excellent communication and coordination skills.
  • Ability to stay updated with regulatory changes and trends.
  • Proficiency in handling audits and compliance checks.
  • Attention to detail and problem-solving abilities.

Application Link

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