Junior Associate- Regulatory Affairs
1 month ago
**Location**:Delhi NCR (Delhi/ Gurgaon)**
**Experience: 1-2-year Experience in Medical devices (Fresher with interest in Medical devices may also apply)**
**Qualifications: B. Pharma/ M Pharma only**
**Job Profile**:
- Regulatory and Quality Assurance for India Sub-continent to support the continuous development, implementation and maintenance of the company’s quality management system and regulatory affairs strategies & submissions.
- Support Internal/External Audits and distributor audits, issue audit reports, follow up on responses, CAPAs and close out internal/distributor audit.
- Manage, plan & execute the preparations, review and submission of dossiers for product registrations, import licenses and other approvals from regulatory agencies (registrations, re-registration and renewals) & line extension indications and labelling approvals of medical devices.
- Manage & execute Head office plan on any Change notification which will require Post Approval Change in India.
- BIS registration for imported electronic and other equipment as per CRS scheme
- Maintain PMS Data and ensure timely reporting of adverse events & Field safety corrective actions to regulatory agencies.
- Responsible for Query resolving raised by DCGI, BIS, WPC, Legal Metrology, Customs or ADC port.
- Coordination with our Head Office and other global regulatory teams for regulatory strategies and all documentation support required for regulatory submissions in Indian sub-continent.
- Supporting the Sales Teams on tender related issues/Documentation.
**Job Type**: Fresher
**Salary**: ₹141,917.06 - ₹400,000.00 per year
Schedule:
- Fixed shift
Ability to commute/relocate:
- Delhi NCR, Delhi - 122002, Delhi: Reliably commute or planning to relocate before starting work (required)
Application Question(s):
- Are you qualified in M. Pharma or B. Pharma?
**Education**:
- Bachelor's (required)
**Experience**:
- medical device: 1 year (required)
- regulatory: 1 year (required)
**Language**:
- English (required)
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