Executive RA Job

Job description

Executive RA-1500071277WDescriptionJohnson & Johnson
- INDIAJob DescriptionJohnson & Johnson – Medical: Johnson & Johnson is the world’s most comprehensive and broadly based manufacturer of health care products.
In India, Johnson & Johnson operates as a single legal entity and consists of the 3 strategic business units: Consumer Products, Pharmaceuticals and Medical Devices which are independently managed and report into their respective Global business segments.
J&J Medical India (JJMI) is the market leader in the Medical Company Devices 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.
Job Title (India Specific): Executive Regulatory AffairsFunction: MedicalLocation: GurgaonPurpose of the position:Strategic Regulatory Affairs & Quality Compliance (SRAQC) department is responsible for regulatory and quality compliance for the entire Johnson & Johnson Medical franchise in India and IB countries. Executive RA coordinates, compiles, and submits New Medical Device Registration Applications, Renewal of Medical Device Registration Applications and Product/Site Change Registration Application to the regulatory agencies for India.
General Responsibilities:Key Activities
- He/she participates in all activities relating to registration requirements and line extension indications.
- 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
- Lifecycle management
- Maintain the changes to the Regulations/Products/Sites and make necessary submission to maintain compliance to Country Regulations
- Follow up and communication with regulatory authorities to obtain timely product approvals.
- Maintenance of RA database for the responsible franchises in Track wise tool (PRIM).
- Control of regulated/ non-regulated products/ codes in RA gateway tool.
- Field action/ adverse event reporting to the regulatory authority, for the responsible franchises
- Review promotional materials for regulatory compliance.
- Attend applicable training sessions as well as complete mandatory on-line trainings and submit training records to the supervisor / franchise secretary and work as per the applicable SOPs and guidelines Follow Bio-Safety practices while handling complaint samples and while working in the field –
- Report any evidence of product tampering, diversion and counterfeiting to the Brand Integrity function –Participate in execution of Field Action (Product Recall, Distribution of Field Safety Alerts, etc.) and complete the assigned tasks in a timely manner.
- Actively participate in implementation of QMS systems/ SOPs.
- Completes other regulatory activities as assigned by Department Head.
QualificationsQualification:
- Post Graduate
- Life science/ Bio Medical/ Pharmacy
- Minimum 3-5 years Industry Experience in Regulatory Affairs (India/ Global), 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 skills1. Reports to (Role): Manager Regulatory Affairs2. No of people reporting
- Individual ContributorPrimary Location:Asia Pacific-India-Haryana-GurgaonOrganization: Johnson & Johnson Private Limited (8080)Job Function: Regulatory Affairs