Regulatory Affairs Manager Jobs in Chennai Medical Device Company

📋 Job Description

Jobzi is sourcing qualified candidates for Regulatory Affairs Manager positions in Chennai's private Medical Device Company sector. This is a full-time opportunity with a reputed Medical Device and Equipment employer in Chennai offering competitive salary, structured growth, and a professional work environment. Tamil communication skills are preferred alongside English for professional and business interaction in Chennai.

📌 Key Responsibilities

• Lead the regulatory affairs team managing CDSCO MDR 2017 registrations, import licences, and state drug authority interactions
• Develop regulatory strategy for new product introductions, including device classification and submission roadmaps
• Coordinate CE marking and USFDA regulatory submissions with Notified Bodies and consultants
• Oversee post-market surveillance activities including adverse event reporting and field safety corrective action management
• Ensure label compliance across the entire product portfolio including UDI implementation and multi-language labelling
• Brief senior management on regulatory timelines, risks, and upcoming CDSCO rule changes
• Build and mentor the regulatory affairs team and manage regulatory consultant relationships

🎓 Qualifications and Requirements

• What is the size and scope of the regulatory portfolio you have managed?
• Have you led CDSCO interactions including query responses and inspection support?
• Have you coordinated CE marking or USFDA submissions for medical devices?
• How do you manage post-market surveillance and adverse event reporting under MDR 2017?
• Describe how you have built or restructured a regulatory affairs team.
• How do you stay current with CDSCO MDR amendments and global regulatory changes?
• What is your approach to regulatory risk management for a large device portfolio?
• Good Tamil and English communication skills for team coordination and client interaction in Chennai.

✅ Required Skills