Regulatory Affairs Manager Jobs in Coimbatore Medical Device Company

📋 Job Description

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

📌 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 Coimbatore.

✅ Required Skills

🏆 Certifications and Qualifications

B.E./B.Tech. (Biomedical, Mechanical, or Electronics) for engineering and field service roles; M.Sc. or B.Sc. in Life Sciences for IVD application and quality roles; ISO 13485 quality management system training; CDSCO MDR 2017 regulatory compliance knowledge for regulatory affairs roles; IEC 60601 and CE marking awareness for quality roles; Lean Manufacturing and GMP training for production roles; BLS and medical device demonstration certification for clinical sales specialists