Looking for a Regulatory Affairs Associate job in Chennai? S3V Vascular Technologies is hiring experienced candidates for its Regulatory Affairs team. Candidates with a background in B.Pharm, M.Pharm, Life Sciences, or Biotechnology and experience in regulatory documentation, dossier preparation, and regulatory submissions are encouraged to apply.
This opportunity is ideal for professionals seeking growth in the medical device regulatory affairs industry with exposure to CTD/eCTD dossiers, lifecycle management, compliance review, and post-market surveillance activities.
About S3V Vascular Technologies
S3V Vascular Technologies is focused on developing innovative cardiovascular medical technologies designed to improve patient outcomes globally. The company works closely with physicians and healthcare professionals to create advanced medical devices and therapies for cardiovascular care.
With a strong emphasis on quality, compliance, and innovation, S3V Vascular Technologies continues to expand its footprint in the Indian healthcare and medical device sector.
Regulatory Affairs Associate Job Details
| Job Role | Regulatory Affairs Associate |
|---|---|
| Company | S3V Vascular Technologies |
| Location | Chennai, Tamil Nadu |
| Job Type | Full-Time |
| Experience | 1โ3 Years |
| Qualification | B.Pharm, M.Pharm, Life Sciences, Biotechnology |
| Industry | Medical Devices / Regulatory Affairs |
| Workplace Type | On-site |
Key Responsibilities
The selected candidate will be responsible for:
- Preparing and reviewing CTD, eCTD, and ACTD dossiers
- Managing new product registrations and renewals
- Handling lifecycle management activities including variations, amendments, and supplements
- Reviewing product labels, IFUs, and promotional materials for regulatory compliance
- Coordinating with R&D, QA, and Clinical teams for technical documentation
- Supporting post-market surveillance and adverse event reporting
- Maintaining audit-ready regulatory databases and trackers
- Assisting in drafting responses to health authority queries
- Ensuring compliance with applicable regional and international regulatory standards
Eligibility Criteria
Candidates applying for this Regulatory Affairs Executive job in Chennai should possess:
Educational Qualification
- B.Pharm
- M.Pharm
- Life Sciences Degree
- Biotechnology Degree
Experience Required
- 1 to 3 years of experience in Regulatory Affairs
- Experience in regulatory documentation and submissions
- Knowledge of regulatory compliance standards
- Familiarity with medical device or pharmaceutical regulations
- Strong analytical and organizational skills
Preferred Skills
- Experience with regulatory submissions
- Knowledge of medical device regulations
- Understanding of post-market surveillance
- Excellent communication and coordination abilities
- Ability to work effectively with cross-functional teams
Salary and Benefits
Candidates selected for this Regulatory Affairs Associate role can expect:
- Competitive salary package
- Exposure to global regulatory practices
- Career growth in medical devices and regulatory affairs
- Collaborative and innovation-driven work environment
- Opportunity to work with experienced industry professionals
Expected Salary Range: โน3.5 LPA โ โน5.5 LPA
How to Apply
Interested candidates can apply directly through the company or contact the hiring team using the details below:
Contact Details
- HR Contact: Dilip Kumar
- Phone: 8870013482
- Email: dilip001jothi@gmail.com
- Official Email: Karthikeyan_m@s3vvascular.com
