Specialist Regulatory Affairs

Work Flexibility: Onsite

What you will need

• Complaint Handling – Review of Complaints as received from various sources (sales Reps / Health Care professionals etc. as per approved SOP and IMDR 2017.Reporting of complaints in Stryker standard System followed by end-to-end closure.

  
  
• Coordinating with Division and Service for product returns/ investigation and closure of received complaints. Coordinating with service for TSR for submission into the Stryker Complaint reporting system for raised complaints.
• Preparation and maintenance of Complaint / SAE trackers. Evaluation of complaints for reporting to CDSCO / MvPI
• Responding to Hold, Recalls initiated by Division and timely evaluation and reporting to local authorities in India. Preparation of MDSAE form for IPC and CDSCO & maintaining Label Master for Imported products
• Periodic review and updates of applicable SOP and Work instructions & responding to internal / external audits, ISO 13485 understanding, preparing and updating checklist of documentation required for New Product Registration/ License Retention / Market Standing Certificates/ Non-Conviction certificates / Test Licenses etc.
• Reviewing of technical Dossiers as per IMDR 2017. Preparing and drafting the DMF and PMF for registrations of all classes as per IMDR 2017. Preparing checklist of PAC as per IMDR 2017
• Good documentation practice for submission & labelling requirement for Medical Devices under various Act.
• Maintaining product approval data base & working knowledge of SUGAM and other Govt portals for files updates. Tender and Institutional support to sales team for documentation: Preparing and sharing the documents as per the requirements of Tenders. BIS Regulations & awareness of EUMDR Regulations, Knowledge of recent amendments in IMDR 2017
• Preparing and maintaining a Monthly dashboard for International and Local communication & preparing power point updates for Monthly Meetings & to prepare QMS procedure through the change control process. Execute the change control process in the Windchill system (one PLM)
• CIDT – To Review received changes in CIDT and execute the change process.

What you need

• BS in Engineering, Science, or related degree; or MS in Regulatory Science
• 3 to 6 yrs experience in to RA