Johnson & Johnson, a global leader in healthcare innovation, is hiring an Executive – Regulatory Affairs for its Medical Devices division in Gurgaon, Haryana. This role offers a chance to work in a hybrid environment while ensuring regulatory compliance, lifecycle management, and coordination with internal and external stakeholders for smooth product registrations and renewals.

If you’re passionate about regulatory affairs in the medical device sector, this is an excellent opportunity to advance your career with one of the world’s most respected healthcare organizations.

🧩 Key Responsibilities

• Draft, review, submit, and archive regulatory filings (new registrations, re-registrations, manufacturer transfers) for the Indian market.
• Prepare and submit regulatory responses, corrections, and notifications per applicable Medical Device Rules, 2017.
• Create and maintain Product Registration Request Forms (PRRF) and manage change controls for product modifications or discontinuations.
• Maintain and update business plans and RA databases in internal systems.
• Coordinate with cross-functional teams to ensure timely documentation for regulatory submissions.
• Attend required training sessions and comply with internal SOPs and regulatory standards.
• Support regulatory strategy development and ensure lifecycle management compliance.

🎓 Qualifications and Core Competencies

• Graduate or preferably Postgraduate in Pharmacy, Life Sciences, Biomedical, or Engineering disciplines.
• Basic understanding of India’s Medical Device Rules, 2017 and CE Marking requirements.
• Strong written and oral communication skills for drafting letters and health authority responses.
• Proficiency in MS Word, Excel, and PowerPoint.
• Ability to work collaboratively across multiple departments and maintain regulatory documentation.

💼 Why Join Johnson & Johnson

• Work for a global healthcare leader known for ethical excellence and innovation.
• Hybrid work flexibility in a collaborative and growth-oriented environment.
• Opportunity to gain experience in regulatory compliance, submissions, and product lifecycle management within the medical devices sector.
• Access to world-class training and development programs.

📝 How to Apply

Application Link