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Regulatory Affairs

2 weeks ago


Sama Vadodara Gujarat, India Topia LifeSciences Full time

**Educational Requirement**: M. Pharma, Medical Devices /Bachelor’s degree with relevant experience

**Experience & Skills**:

- 2-3 Years of experience in Medical Devices, preferably active devices
- Strong communication and drafting skills
- Familiarity with EU MDR 2017/745 (CE Marking) & FDA 510 (K) Process

**Key Responsibility**:

- Identify Product Registration Requirements and preparing Dossiers for submission
- DMF preparation and compilation
- Risk Management
- Labelling Requirements for Active devices

**Job Type**: Permanent

Pay: ₹200,000.00 - ₹400,000.00 per year

**Benefits**:

- Health insurance
- Provident Fund

Schedule:

- Monday to Friday

Work Location: In person