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Job Description:

Overall purpose of job:
• Regulatory and quality compliance for Johnson & Johnson Medical franchises in India
• To maintain the Life cycle management of the product registered by Johnson & Johnson under
• To develop regulatory strategies along with internal stakeholders to coordinate and mitigate
interdependencies of overlapping projects to successfully submit application to HA averting any
business impact
• Ensures compliance with regulatory agency regulations and interpretations
Key responsibilities:
• Draft, review and submission of Regulatory filings (Re-registrations/ New Registrations/ Legal-
Physical manufacturer transfer) for India market.
• Draft, review and submission of other Regulatory submissions (Query responses, Corrections
fillings, miscellaneous notifications regarding post registration regulatory lifecycle management)
for India market in accordance with applicable regulations and relevant guidelines.
• Draft cover letters for Regulatory communications/ submissions depending on level of regulatory
knowledge/expertise
• Update and live maintenance of business plan in sharepoint for assigned franchises/ licenses.
• Assist in the preparation of technical presentations/ meetings with regulator
• Ensures compliance with regulatory agency regulations and interpretations.
• Gathers and assembles information, prepares documents for New Product Applications/Renewal
• Applications/Change Notifications/Response to Regulatory Agencies questions in accordance with
regulations and relevant guidelines
• Maintain the changes to the Regulations/Products/Sites and make necessary submission to
maintain compliance to Country Regulations (Lifecycle management)
• Coordination with internal stakeholders ensuring compliant lifecycle management of responsible
products/franchises.
• Maintain the changes to the Regulations/Products/Sites and make necessary submission to
maintain compliance to Country Regulations
• Attend applicable training sessions as well as complete mandatory on-line e University trainings
and submit training records to the supervisor / Admin assistant and work as per the applicable
SOPs and guidelines.
• Maintenance of RA database for the responsible franchises in MDRIM tool.
• Ensuring timely completion of received change assessment within due timeline and provide feedback to source RA team through email/other portals.
• Ensuring timely completion of assigned Quality issues/ Corrective Actions in ETS system.

Required Qualification and Core Competencies for the role:
• Strong knowledge of Medical Device Rule 2017
• Strong knowledge of Drugs and Cosmetics Act
• Knowledge in the international regulations of Medical Devices in US and EU
• Sound knowledge on Medical Device Quality Management System ISO 13485
• Excellent proficiency with software tools

Job location:
Gurgaon, India