Job details
Salary
₹1,41,917 – ₹4,00,000 a year
Job Type
Fresher
Qualifications
– Bachelor’s (Required)
– medical device: 1 year (Required)
– regulatory: 1 year (Required)
– English (Required)
Full Job Description
Location: Delhi NCR (Delhi/ Gurgaon)
Experience: 1–2-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’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)
Education:
– Bachelor’s (Required)
Experience:
– medical device: 1 year (Required)
– regulatory: 1 year (Required)
Language:
– English (Required)
Hiring Insights
Hiring 1 candidate for this role
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