Advin Health Care, a global leader in innovative and high-quality medical devices, is hiring a Regulatory Affairs Officer at its Ahmedabad facility. This opportunity is ideal for freshers and early-career professionals (0–1 year experience) seeking hands-on exposure to CDSCO submissions, ISO 13485 certification, and global medical device regulations.
If you are looking to build a long-term career in medical device regulatory affairs, this role offers structured learning, real-time regulatory exposure, and a clear growth pathway toward Regulatory Specialist roles for Class II & Class III medical devices.
🔍 Key Responsibilities – Regulatory Affairs Officer
- Prepare and support CDSCO medical device submissions as per Medical Device Rules (MDR), 2017
- Assist in ISO 13485 certification and documentation activities
- Support MDSAP and international regulatory registrations
- Interpret regulatory requirements and execute assigned tasks accurately
- Maintain regulatory documentation and compliance records
- Collaborate with Quality Assurance and cross-functional teams
- Gain exposure to real-time regulatory compliance in a manufacturing environment
🎓 Qualifications & Eligibility Criteria
- Bachelor’s Degree in:
- Engineering
- Life Sciences
- Biomedical / Mechanical Engineering
- Polymer Science
- Pharmacy
- Experience: 0–1 year (Freshers may apply)
- Internship or academic project exposure in Regulatory Affairs / Quality Assurance preferred
🧠 Desired Skills & Knowledge
- Awareness of CDSCO Medical Device Rules, 2017
- Understanding of ISO 13485 Quality Management Systems
- Basic knowledge of US FDA and EU MDR (added advantage)
- Strong analytical and documentation skills
- Ability to understand regulatory tasks and take ownership
💼 What Advin Health Care Offers
- Opportunity to build, lead, and grow a regulatory career in MedTech
- Hands-on exposure to real-time regulatory submissions
- Learning-oriented, team-driven work culture
- Clear roadmap toward Class II & Class III medical device regulatory roles
- Experience with global regulatory frameworks
💰 Salary & Compensation (Indicative)
- ₹2.5 – ₹4.0 LPA (Based on qualifications, skills, and experience)
📍 Job Location
Advin Health Care
Aarna Fortune, B/H Chittvan
South Bopal, Ahmedabad, Gujarat – India
📧 How to Apply
Interested candidates can apply through the following channels:
- 📩 Email: regulatory@advinhealthcare.com
