Job Description

JOB POSITION SUMMARYThe executive regulatory affairs have the responsibility to Supports regulatory department to ensure efficient and compliant business processes and environment. Assists with Document Management & Archival, preparation and management of Local Label Artwork along side the registration of products as per the business plan. Manage the data accuracy in MDRIM for all applications submitted and approved through health authority. Supports with Tender requests Management on a need basis and also fulfills any other assignment identified and assigned by Supervisor/ management- time to time.DUTIES & RESPONSIBILITIES

• Draft, compilation, and submission of regulatory filing
• Update the matrices upon getting any life cycle changes, import licenses or other approval from various ministries applicable for Medical devices.
• Attend applicable training sessions as well as complete mandatory trainings
• Generate artwork and maintain master, for all licenses with receipt of new licenses and as & when required by Legal metrology/local regulations/J&J policies/D&C Acts and Rules.
• Maintain and update license and artwork of each product code across all Franchise
• Ensure blocking/unblocking of codes upon license expiry/renewal respectively.
• Responsible for update and maintenance of Tender related Share Points.
• SOP & WI update on internal repositories
• Other assignment identified and assigned by management- time to time.
• Ensure compliance to document archival for the regulatory submission to Health Authority.
• Manage RA Change controls
• Maintain, Monitor and Publish RA metrices and monthly reports
• Prepare, review and submit product registration dossier for New products, post approval change or renewal, on CDSCO MD-online portal

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES AND AFFILIATIONSStrong communication, organizational, and interpersonal skills. Knowledge, understanding and application of principles concepts and practices of various government regulations. Ability to organize and analyze technical data and identify issues or gaps. Foundational regulatory knowledge to maintain legal status of products and minimize risk. Self- motivated and committed to a team approach.LOCATION & TRAVEL REQUIREMENTSLocation xe2x80x93 GurugramTravel xe2x80x93 On need basisQualificationsEXPERIENCE & EDUCATION

• Typically requires Masters or Bachelor of any Life Science Degree
• 2 - 4 Years of experience in Medical Device regulatory Affairs

Good Knowledge of MS office especially in Excel.

Johnson & Johnson