Are you a seasoned regulatory affairs professional looking for a new challenge in the medical devices industry? We are hiring a Regulatory Affairs Professional with hands-on experience in active medical devices and end-to-end regulatory approvals. 🌟
About the Role 📝
As a Regulatory Affairs Professional, you will play a critical role in ensuring compliance with regulatory requirements for medical devices. Your responsibilities will include:
- Technical Files & Design Dossier: Preparing and maintaining technical files and design dossiers for medical devices.
- Regulatory Approvals: Obtaining regulatory approvals from CDSCO and EU MDR.
- Risk Management: Implementing risk management practices according to ISO 14971.
- Post-Market Activities: Managing post-market activities, including quality assurance and compliance with ISO 13485.
- External Audits: Supporting external audits and ensuring compliance with regulatory requirements.
Requirements 📚
- Experience: 3-7 years of experience in regulatory affairs for medical devices.
- Technical Knowledge: Hands-on experience with technical files, design dossiers, and regulatory approvals.
- Risk Management: Experience with risk management practices according to ISO 14971.
- Quality Assurance: Knowledge of quality assurance practices according to ISO 13485.
What You Can Expect 🌟
- Career Growth: Opportunities for career growth and professional development.
- Competitive Salary: A competitive salary and benefits package.
- Collaborative Team: Work with a team of experienced professionals who share your passion for regulatory affairs.
Why you Choose This Role? 🤔
- Industry Leader: Opportunity to work with a leading company in the medical devices industry.
- Innovative Solutions: Opportunity to work on innovative solutions that transform healthcare and improve patient outcomes.
- Collaborative Team: Work with a team of experienced professionals who share your passion for regulatory affairs.
How to Apply 📧
If you’re interested in this exciting opportunity, send your CV to vijayalakshmi@peoplefirst.co.in
Tips for Regulatory Affairs Professionals 📝
- Stay Current: Stay up-to-date with the latest developments and trends in regulatory affairs for medical devices.
- Develop Strong Analytical Skills: Develop strong analytical skills to effectively manage technical files and regulatory approvals.
- Improve Your Communication Skills: Improve your communication skills to effectively collaborate with cross-functional teams.
Benefits of Working in Regulatory Affairs 🌟
- Career Growth: Opportunities for career growth and professional development.
- Competitive Salary: A competitive salary and benefits package.
- Variety: Opportunity to work on different projects and products.