Regulatory Affairs Executive Jobs in Chennai Medical Device Company
⚡ Hiring Now🏫 Chennai Medical Device Company Employment Zones
Chennai's private medical device companies distribute, service, and manufacture medical equipment, surgical instruments, and diagnostic devices from Guindy and Ambattur MIDC, employing Tamil-speaking biomedical engineers, medical sales executives, and service technicians.
Medical Device Company employment zones in Chennai include Guindy, Ambattur MIDC, Sholinganallur, Anna Nagar, Nungambakkam, T. Nagar, Adyar, Velachery, Taramani, and Perungudi.
📋 Job Description
Jobzi is sourcing qualified candidates for Regulatory Affairs Executive 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
- 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 Chennai.
✅ 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
Frequently Asked Questions
What types of jobs are available in medical device companies in Chennai?
Private medical device companies in Chennai hire across manufacturing, quality, engineering, sales, and regulatory functions. Production operators and quality inspectors work on the shopfloor in cleanroom assembly. Field service engineers and application specialists support hospitals and diagnostic labs. Sales executives and product managers drive revenue through hospital and distributor channels. Regulatory affairs and quality assurance professionals manage CDSCO MDR 2017 compliance, ISO 13485 audits, and international device registrations.
What qualifications and certifications are needed for medical device jobs in Chennai?
Engineering roles require B.E./B.Tech. in Biomedical, Mechanical, or Electronics. Life science roles require M.Sc. or B.Sc. in relevant subjects. ISO 13485 QMS awareness is valued across quality and manufacturing roles. CDSCO MDR 2017 knowledge is essential for regulatory affairs. IEC 60601 electrical safety and CE marking exposure helps in quality engineering. GMP and Lean Manufacturing training strengthens production candidatures. Field service and clinical sales roles benefit from BLS certification and device demonstration skills.
What is the salary range and career growth in the medical device sector in Chennai?
Entry-level production and quality roles in Chennai medical device companies typically start between Rs.13,000 and Rs.32,000 per month. Mid-level field service engineers and application specialists earn Rs.22,000 to Rs.68,000. Sales managers, regulatory managers, and QA managers earn Rs.45,000 to Rs.1,15,000. Senior leadership such as business development managers and general managers can earn Rs.55,000 to Rs.2,80,000 or more. Career growth pathways lead from technical roles into product management, clinical sales, or regulatory leadership.
What does a Regulatory Affairs Executive do in a Chennai medical device company?
A Regulatory Affairs Executive in a Chennai medical device company manages CDSCO MDR 2017 device registrations, import licence applications, and labelling compliance. They prepare technical documentation files, submit applications on the SUGAM portal, track licence renewals, and coordinate with manufacturers for required documents. They monitor regulatory updates and brief internal teams on new requirements. Companies importing or distributing medical devices in India rely on regulatory affairs executives to maintain a compliant product portfolio.
What is MDR 2017 and why is it important for medical device jobs in Chennai?
MDR 2017 refers to the Medical Devices Rules 2017 notified under the Drugs and Cosmetics Act in India, governing the manufacture, import, sale, and distribution of medical devices. Under MDR 2017, all medical devices require CDSCO registration before being marketed in India. Chennai-based medical device companies importing equipment or manufacturing devices for the domestic market must comply with MDR 2017 registration, labelling, and post-market surveillance requirements. Regulatory affairs professionals with MDR 2017 expertise are consistently in demand in Chennai.
What is the salary for a Regulatory Affairs Executive in a Chennai medical device company?
Regulatory Affairs Executives in Chennai medical device companies earn between Rs.22,000 and Rs.55,000 per month depending on experience, device classes handled, and submission volumes. Candidates with hands-on SUGAM portal submission experience and technical file preparation skills command the higher end of this range. Most companies offer structured salary increments linked to registration milestones and team performance. Regulatory affairs is a specialised function with limited qualified candidates, which supports above-average salary progression compared to general administrative roles.
What is the salary for Regulatory Affairs Executive in Chennai Medical Device Company in
A Regulatory Affairs Executive in Chennai earns between Rs.24,000 and Rs.57,000 per month in July 2026, depending on experience, skills, and employer.
What experience is required for Regulatory Affairs Executive jobs in
1 - 5 Years of relevant experience is typically required for Regulatory Affairs Executive positions in Chennai's private Medical Device Company sector.
வேலை விவரம் - தமிழில்
Chennai-ல் Regulatory Affairs Executive வேலைவாய்ப்பு. மாத சம்பளம் ரூ.24,000 முதல் ரூ.57,000 வரை. 1 - 5 Years અனுபவம் தேவை. Medical Device Company-ல் Full Time பணி. ஆர்வமுள்ளவர்கள் Jobzi மூலம் விண்ணப்பிக்கலாம்.