At Johnson & Johnson, we believe health is everything. Our expertise in Innovative Medicine and MedTech allows us to pioneer healthcare solutions that prevent, treat, and cure complex diseases. We are committed to delivering smarter, less invasive treatments and personalized healthcare breakthroughs that profoundly impact humanity.
Learn more about us at www.jnj.com.
Job Description: Assistant Manager – Regulatory Affairs
Key Responsibilities:
- Regulatory Compliance: Ensure adherence to Medical Device Rule 2017, Drugs and Cosmetics Act, and other relevant regulations in India.
- Regulatory Submissions: Prepare, review, and submit regulatory filings for new registrations, re-registrations, manufacturer transfers, and post-approval changes.
- Lifecycle Management: Maintain compliance for product registrations, including change notifications, query responses, and regulatory updates.
- Regulatory Strategy:Â Collaborate with internal stakeholders to develop regulatory strategies and mitigate business risks.
- Documentation & Reporting:Â Draft cover letters, maintain regulatory databases (MDRIM tool), and ensure timely submissions.
- Quality Compliance: Address quality issues, corrective actions (ETS system), and regulatory assessments within deadlines.
- Stakeholder Coordination:Â Work with cross-functional teams to ensure compliant product lifecycle management.
- Training & SOPs: Complete mandatory training and follow SOPs and regulatory guidelines.
Required Qualifications & Skills:
- Strong knowledge of Medical Device Rule 2017, Drugs and Cosmetics Act, and ISO 13485 (QMS).
- Familiarity with US FDA and EU MDR regulations for medical devices.
- Proficiency in regulatory databases and software tools.
- Excellent communication, documentation, and project management skills.
- Ability to interpret regulatory guidelines and ensure compliance.
Why Join Johnson & Johnson?
- Global Impact: Work on cutting-edge healthcare innovations that improve lives worldwide.
- Hybrid Work Model:Â Flexible work arrangements for better work-life balance.
- Career Growth: Opportunities for professional development in a leading healthcare company.
- Inclusive Culture: Be part of a diverse and dynamic team that values collaboration.
How to Apply
Advertisement
