Regulatory Affairs Executive Jobs in Coimbatore Medical Device Company

📋 Job Description

Jobzi is sourcing qualified candidates for Regulatory Affairs Executive 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

• Prepare and submit medical device registration applications on the CDSCO SUGAM portal under MDR 2017
• Compile technical documentation files including test reports, clinical evaluations, and manufacturer declarations
• Apply for and renew import licences for medical devices from CDSCO and state drug licensing authorities
• Ensure device labelling complies with MDR 2017 requirements including UDI and language specifications
• Maintain regulatory dossiers, correspondence logs, and licence expiry tracking systems
• Coordinate with manufacturers and global regulatory teams for document sourcing and gap closure
• Monitor CDSCO notifications, circulars, and MDR amendment updates and brief internal stakeholders

🎓 Qualifications and Requirements

• Have you filed medical device registrations on the CDSCO SUGAM portal before?
• Which device classes - Class A, B, C, or D - have you handled regulatory submissions for?
• Are you familiar with MDR 2017 technical file requirements and clinical evaluation report structure?
• Have you applied for import licences or state drug authority approvals for medical devices?
• How do you track licence expiry and renewal timelines across a large device portfolio?
• Are you familiar with UDI requirements under MDR 2017?
• Have you coordinated with foreign manufacturers for regulatory document submissions?
• 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