Job Description

Location: Delhi NCR (Delhi/ Gurgaon) Experience: 1\xe2\x80\x932-year Experience in Medical devices (Fresher with interest in Medical devices may also apply) Qualifications: B. Pharmacy only Job Profile: Regulatory and Quality Assurance for India Sub-continent to support the continuous development, implementation and maintenance of the company\xe2\x80\x99s 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: 9141,917.06 - 9400,000.00 per year Schedule:

• Fixed shift

Ability to commute/relocate:

• Delhi NCR, Delhi - 122002, Delhi: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor\'s (Required)

Experience:

• medical device: 1 year (Required)
• regulatory: 1 year (Required)

Language:

• English (Required)