RegTrac, a global leader in Regulatory Affairs and Quality Systems for medical devices, is hiring a Senior Regulatory Affairs Associate in Chennai, Tamil Nadu.
This full-time, on-site role is ideal for experienced professionals passionate about EU MDR compliance, clinical documentation (CER/CEP), and quality management systems (QMS).
At RegTrac, you’ll play a key role in supporting regulatory submissions, ensuring compliance with ISO 13485, 14971, and 10993 standards, and managing client relationships across global markets.
🧩 Key Responsibilities
As a Senior Regulatory Affairs Associate – Medical Devices, you will:
- Prepare and review Clinical Evaluation Reports (CER), Clinical Evaluation Plans (CEP), and technical files for CE/UKCA marking.
- Lead regulatory projects ensuring EU MDR compliance for clients in Europe.
- Oversee medical device labeling review and approval processes.
- Support sales and proposal teams with regulatory analysis and project estimation.
- Stay updated with evolving global regulatory requirements and communicate changes internally.
- Manage and strengthen client relationships through regular feedback sessions.
- Author, review, and approve QMS-related procedures to maintain ISO compliance.
- Collaborate with QA teams during internal and external audits.
- Monitor supplier and customer quality metrics, ensuring prompt issue resolution.
- Provide strategic regulatory guidance to internal and external stakeholders.
🎓 Qualifications
- Master’s or PhD in Life Sciences, Pharmacy, Biomedical Engineering, or a related field.
- Minimum 5 years of experience in Regulatory Affairs, Quality Assurance, or Medical Device Governance.
- Strong understanding of ISO 13485, ISO 14971, and ISO 10993.
- Proven expertise in EU MDR documentation and submissions.
- Excellent communication, analytical, and problem-solving skills.
- Self-motivated, detail-oriented, and capable of managing multiple client projects.
- Ability to collaborate across cross-functional and multicultural teams.
💼 Why Join RegTrac?
At RegTrac, you’ll find more than a job — you’ll find a mission-driven career in advancing medical device compliance and innovation.
- 🌍 Exposure to global regulatory projects
- 📈 Continuous learning and professional growth opportunities
- 🤝 Collaborative and supportive team culture
- 🕓 Flexible environment encouraging work-life balance
- 💬 Real impact on healthcare quality and patient safety
📝 How to Apply
