MED-EL India Privated Ltd Hiring for Junior Associate- Regulatory Affairs (Medical Devices) at New Delhi Full Time

Position: Junior Associate- Regulatory Affairs (Medical Devices)

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

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: Full-time

Salary: ₹240,000.00 – ₹360,000.00 per year

Schedule:

• Fixed shift

Ability to commute/relocate:

• Delhi, Gurgaon, Delhi – 110019, Delhi: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor’s (Required)

Experience:

• regulatory affairs: 1 year (Required)

Language:

• English (Required)