Regulatory Affairs Manager 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 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
🏆 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 Manager do in a Chennai medical device company?
A Regulatory Affairs Manager in a Chennai medical device company leads the regulatory strategy for the entire device portfolio covering CDSCO MDR 2017 registrations, import licences, CE marking, and USFDA submissions where applicable. They manage the regulatory team, brief leadership on risks and timelines, oversee post-market surveillance and adverse event reporting, and ensure label compliance. Companies with large or growing device portfolios and international sourcing rely heavily on experienced regulatory affairs managers.
What is the salary for a Regulatory Affairs Manager in Chennai?
Regulatory Affairs Managers in Chennai medical device companies earn between Rs.45,000 and Rs.1,05,000 per month based on portfolio complexity, team size, and regulatory scope. Managers handling multi-country submissions including CDSCO, CE, and USFDA earn at the higher end. Regulatory affairs management is a specialised role with talent scarcity, which gives experienced professionals strong salary negotiation leverage. Annual performance bonuses linked to registration milestones and portfolio growth are common in this role.
What is the difference between Regulatory Affairs Executive and Manager roles in Chennai medical device companies?
A Regulatory Affairs Executive handles day-to-day CDSCO registration filings, SUGAM portal submissions, import licence applications, and document compilation. A Regulatory Affairs Manager leads the team, owns the regulatory strategy, manages relationships with Notified Bodies and CDSCO officials, and oversees CE and USFDA submissions in addition to India-specific work. Managers are responsible for post-market surveillance, adverse event reporting oversight, and regulatory risk briefing to senior management. The transition typically requires 5 or more years of hands-on regulatory work.
What is the salary for Regulatory Affairs Manager in Chennai Medical Device Company in
A Regulatory Affairs Manager in Chennai earns between Rs.46,000 and Rs.1,06,000 per month in July 2026, depending on experience, skills, and employer.
What experience is required for Regulatory Affairs Manager jobs in
5 - 12 Years of relevant experience is typically required for Regulatory Affairs Manager positions in Chennai's private Medical Device Company sector.
வேலை விவரம் - தமிழில்
Chennai-ல் Regulatory Affairs Manager வேலைவாய்ப்பு. மாத சம்பளம் ரூ.46,000 முதல் ரூ.1,06,000 வரை. 5 - 12 Years અனுபவம் தேவை. Medical Device Company-ல் Full Time பணி. ஆர்வமுள்ளவர்கள் Jobzi மூலம் விண்ணப்பிக்கலாம்.