At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function

Regulatory Affairs Group

Job Sub Function

Regulatory Affairs

Job Category

Professional

All Job Posting Locations:

IN018 Gurgaon

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