Junior Regulatory Affairs

Location: Ahmedabad, Gujarat

Employment Type: Full-Time

Experience Required: 1–2 Years

Educational Qualification

• Bachelor's or Master's degree in Pharmacy, Biomedical Engineering, Biotechnology, Microbiology, Life Sciences, Biochemistry, or a related field.
• Candidates with experience in medical device or IVD regulatory affairs (CDSCO) are mandatory.

Job Summary

We are seeking a Junior Regulatory Executive with 1–2 years of experience in Indian Medical Device Regulations to support regulatory submissions, licensing activities, and compliance requirements under CDSCO. The candidate will be responsible for preparing regulatory documentation, coordinating with clients, and supporting medical device and IVD registration activities in accordance with the Medical Devices Rules (MDR), 2017.

Key Responsibilities

CDSCO Regulatory Activities

• Prepare and review regulatory submissions for medical devices and IVDs under CDSCO requirements.
• Assist in obtaining manufacturing licenses, import licenses, and other regulatory approvals under the Medical Devices Rules, 2017.
• Support preparation and compilation of applications through the SUGAM Portal.
• Coordinate with clients for collection of required regulatory and technical documentation.
• Track application progress and respond to CDSCO queries within defined timelines.
• Monitor updates, notifications, guidance documents, and amendments issued by CDSCO.

Regulatory Documentation

• Prepare and review Device Master Files (DMF) and Plant Master Files (PMF).
• Review product labelling, Instructions for Use (IFU), packaging artwork, and associated documentation for regulatory compliance.
• Support the preparation of declarations, undertaking letters, authorisation letters, and regulatory dossiers.
• Maintain regulatory records, submission trackers, and licensing databases.

Medical Device Classification & Compliance

• Assist in the classification of medical devices and IVDs as per CDSCO classification rules.
• Conduct regulatory gap assessments against applicable CDSCO requirements.
• Support compliance activities related to licensing, registration, and post-approval changes.
• Ensure documentation complies with applicable Indian regulatory requirements.

Client Coordination

• Communicate with clients regarding documentation requirements, project timelines, and regulatory updates.
• Support project execution and ensure the timely completion of assigned activities.
• Prepare status reports and regulatory updates for internal and client review.

Required Knowledge

• Good understanding of Medical Devices Rules (MDR), 2017.
• Knowledge of the CDSCO regulatory framework for medical devices and IVDs.
• Understanding of device classification (Class A, B, C, and D).
• Familiarity with manufacturing and import licensing processes.
• Understanding of Device Master File (DMF) and Plant Master File (PMF) requirements.
• Working knowledge of the CDSCO SUGAM Portal.
• Basic understanding of ISO 13485 and medical device quality management systems.

Required Skills

• Strong documentation and technical writing skills.
• Good communication and client coordination abilities.
• Attention to detail and a regulatory compliance mindset.
• Ability to interpret regulatory guidelines and requirements.
• Proficiency in Microsoft Word, Excel, and PowerPoint.
• Ability to manage multiple projects and deadlines.