ncvet-help[at]gov[dot]in
Beta Version
+91 11 25788001-11
  • Home
  • Qualifications Search
  • Associate- Regulatory Affairs and Intellectual Property (Medical Devices) Options: 1. Regulated Business Operations

Associate- Regulatory Affairs and Intellectual Property (Medical Devices) Options: 1. Regulated Business Operations

NQR Code:QG-06-LS-04425-2025-V2-LSSSDC

  • Old Code: QG-06-LS-04425-2025-V2-LSSSDC

    Copy
About this Qualification

Job Description

Associate- Regulatory Affairs and Intellectual Property (Medical Devices) prepares dossiers and liaison with regulatory bodies in India and relevant overseas markets to support appropriate approvals at various levels of technology readiness during product development, as well as for manufacturing, marketing and import license to ensure regulatory and legal compliance of Medical Devices in targeted markets. The job holder also facilitated in securing quality certification like CE, ISO, IEC, BIS, ICMED etc for the medical devices. The job role holder carries out proper documentation and reporting for dossier preparation and assist in patent filing for intellectual property management of innovations in medical devices.

Eligibility Criteria

Criteria 1 Criteria 2 Experience Training Qualification
4 year UG degree Completed No Experience None
UG Completed No Experience None
PG Completed No Experience None
Diploma Completed 2.5 Years None
3 year UG degree Completed 3 years None
4 year UG degree Completed No Experience None

Progression Pathway

  • Not Available

Learning Module In Job Role/Qualifcation

National Occupation Standards (NOS)/Module NOS Code Mandatory/ Optional Estimated size (Hours) Nos Credit Level
Introduction to the Life sciences Sector and Fundamentals of Regulatory Affairs in IVD and Medical Devices Industry LFS/N0582 v1 Mandatory 30 1.00 6
Development of Technical Dossier as per the regulatory guidelines of intended market (India and Global) for medical devices LFS/N0570 v2.0 Mandatory 120 4.00 6
Submission of Technical Dossier as per the regulatory guidelines LFS/N0502 v3.0 Mandatory 90 3.00 6
Assist in managing the regulatory affairs for medical devices and In-vitro Diagnostic Devices (IVD) LFS/N0569 v2.0 Mandatory 120 4.00 6
Assist in intellectual property rights management for life sciences products and assets LFS/N0571 v2.0 Mandatory 60 2.00 6
Coordinate with Manager, R&D team, other cross-functional teams, external stakeholders and regulatory agencies to manage regulatory affairs operations LFS/N0567 v2.0 Mandatory 60 2.00 6
Ensure adherence to Environment, health and safety guidelines at workplace by self and subordinates LFS/N0122 v2.0 Mandatory 30 1.00 6
Employability Skills (60 Hours) DGT/VSQ/N0102 Mandatory 60 2.00 4
Option NOS/s: Regulated Business Operations: Establish own enterprise and perform various entrepreneurial activities to run the business operations in Life Sciences Sector LFS/N0120 v3.0 Optional 30 1.00 6
Option NOS/s: Regulated Business Operations: Maintain the critical business documents as Entrepreneur in Life Sciences Sector LFS/N0121 v3.0 Optional 30 1.00 6