Caring
for the world, one person at a time... inspires and unites the people
of Johnson & Johnson. We embrace research and science - bringing
innovative ideas, products and services to advance the health and
well-being of people. Employees of the Johnson & Johnson Family
of Companies work with partners in health care to touch the lives of
over a billion people every day, throughout the world.
Post: Executive - RA
Job Description
J&J Medical India (JJMI) is the market leader in the Medical Company Devices & Diagnostics Industry in India. It is in the business of caring and providing solutions to doctors, patients and nurses. It comprises of multiple Franchises (Strategic business units) providing healthcare solutions across Vision Care, Orthopaedics, Infection Prevention, Wound Management, Women’s health, Minimally invasive surgery, Circulatory disease management, and Blood glucose monitoring and insulin delivery.
J&J Medical India (JJMI) is the market leader in the Medical Company Devices & Diagnostics Industry in India. It is in the business of caring and providing solutions to doctors, patients and nurses. It comprises of multiple Franchises (Strategic business units) providing healthcare solutions across Vision Care, Orthopaedics, Infection Prevention, Wound Management, Women’s health, Minimally invasive surgery, Circulatory disease management, and Blood glucose monitoring and insulin delivery.
Responsibilities/Accountabilities:
- Compilation, review and submissions of Regulatory filings for India
- 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
- Provides regulatory advice to project teams
- Organizes and maintains reports of schedules for new Medical Device applications and Renewal Applications.
- Attend applicable training sessions as well as complete mandatory on-line e University trainings and submit training records to the supervisor / franchise secretary and work as per the applicable SOPs and guidelines
- Participate in execution of Field Action (Product Recall, Distribution of Field Safety Alerts, etc.) and complete the assigned tasks in a timely manner
- Understand complaint & adverse event reporting responsibility and report such events within 24 hours of becoming aware
- Compilation, review and submissions of Regulatory filings for India
- 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
- Provides regulatory advice to project teams
- Organizes and maintains reports of schedules for new Medical Device applications and Renewal Applications.
- Attend applicable training sessions as well as complete mandatory on-line e University trainings and submit training records to the supervisor / franchise secretary and work as per the applicable SOPs and guidelines
- Participate in execution of Field Action (Product Recall, Distribution of Field Safety Alerts, etc.) and complete the assigned tasks in a timely manner
- Understand complaint & adverse event reporting responsibility and report such events within 24 hours of becoming aware
Candidate Profile
- Post Graduate- Life Science/ Bio Medical/ Pharmacy
- Minimum 5-6 years Industry Experience in Regulatory Affairs, preferably in medical devices.
- Experience of Submitting, Registering and maintaining Product registrations with MOH
- Experience in quality/ manufacturing and regulatory affairs in medical devices would be advantage
- Experience in assembling product dossiers for submission to Regulatory Authorities.
- Good technical writing skills.
- Post Graduate- Life Science/ Bio Medical/ Pharmacy
- Minimum 5-6 years Industry Experience in Regulatory Affairs, preferably in medical devices.
- Experience of Submitting, Registering and maintaining Product registrations with MOH
- Experience in quality/ manufacturing and regulatory affairs in medical devices would be advantage
- Experience in assembling product dossiers for submission to Regulatory Authorities.
- Good technical writing skills.
Additional Information:
Experience: 5-6 years
Qualification: Post Graduate- Life Science/ Bio Medical/ Pharmacy
Location: Delhi
Functional Area: DRA
Industry Type: Pharma/Biotech/Clinical Research
End Date: 30th June, 2015
Experience: 5-6 years
Qualification: Post Graduate- Life Science/ Bio Medical/ Pharmacy
Location: Delhi
Functional Area: DRA
Industry Type: Pharma/Biotech/Clinical Research
End Date: 30th June, 2015
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