Are you looking for a Junior Regulatory Affairs job in Ahmedabad? Maven Profcon Services LLP is inviting applications from qualified professionals with experience in medical device regulatory affairs, CDSCO compliance, and Medical Devices Rules (MDR) 2017.
This is an excellent opportunity for candidates with 1–2 years of experience in medical device and IVD regulatory affairs who want to build a rewarding career in regulatory compliance, medical device registration, and CDSCO licensing activities.
Job Overview
| Details | Information |
|---|---|
| Position | Junior Regulatory Affairs |
| Company | Maven Profcon Services LLP |
| Location | Ahmedabad, Gujarat, India |
| Employment Type | Full-Time |
| Experience | 1–2 Years |
| Industry | Regulatory Affairs, Medical Devices, IVD |
| Work Mode | On-Site |
Key Responsibilities
CDSCO Regulatory Activities
- Prepare and review regulatory submissions for medical devices and IVDs.
- Support manufacturing license and import license applications under Medical Devices Rules (MDR), 2017.
- Prepare and submit applications through the CDSCO SUGAM Portal.
- Coordinate with clients to collect regulatory and technical documentation.
- Track application status and respond to CDSCO queries.
- Monitor CDSCO notifications, amendments, and regulatory updates.
Regulatory Documentation
- Prepare and review Device Master Files (DMF).
- Prepare and review Plant Master Files (PMF).
- Review product labels, Instructions for Use (IFU), packaging artwork, and compliance documents.
- Compile declarations, authorization letters, undertakings, and regulatory dossiers.
- Maintain regulatory databases and submission trackers.
Medical Device Compliance
- Assist in medical device and IVD classification activities.
- Conduct regulatory gap assessments.
- Support licensing, registration, and post-approval compliance activities.
- Ensure documentation meets Indian regulatory requirements.
Client Coordination
- Communicate with clients regarding regulatory requirements and project timelines.
- Support project execution and timely completion of deliverables.
- Prepare regulatory status reports and client updates.
Educational Qualification
Candidates should possess any of the following:
- Bachelor’s Degree in Pharmacy (B.Pharm)
- Master’s Degree in Pharmacy (M.Pharm)
- Biomedical Engineering
- Biotechnology
- Microbiology
- Life Sciences
- Biochemistry
- Related Scientific Discipline
Mandatory Requirement: Experience in Medical Device or IVD Regulatory Affairs under CDSCO regulations.
Required Knowledge
Candidates should have knowledge of:
- Medical Devices Rules (MDR), 2017
- CDSCO Medical Device Regulations
- Medical Device Classification (Class A, B, C, D)
- Manufacturing and Import Licensing Processes
- Device Master File (DMF)
- Plant Master File (PMF)
- CDSCO SUGAM Portal
- ISO 13485 Quality Management Systems
Required Skills
- Regulatory documentation and technical writing
- Regulatory compliance management
- Client coordination and communication
- Regulatory guideline interpretation
- Microsoft Word, Excel, and PowerPoint
- Project management and multitasking
- Attention to detail
Why Join Maven Profcon Services LLP?
- Exposure to CDSCO medical device regulatory projects
- Hands-on experience with medical device licensing and registration
- Opportunity to work on IVD and medical device submissions
- Career growth in regulatory affairs and compliance
- Collaborative and professional work environment
Who Should Apply?
This opportunity is ideal for:
- B.Pharm graduates with regulatory affairs experience
- M.Pharm professionals seeking CDSCO regulatory careers
- Medical device regulatory affairs executives
- IVD regulatory professionals
- Candidates experienced with SUGAM Portal submissions
- Regulatory compliance professionals in healthcare and life sciences
How to Apply
