Regulatory Affairs Associate

3 days ago


Gurgaon, Haryana, India Stryker Full time

Stryker is a global leader in medical technologies, driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics, and Spine that help improve patient and healthcare outcomes.

As a Regulatory Affairs Associate at Stryker, you will be responsible for Complaint Handling Review of Complaints as received from various sources. You will report complaints in Stryker's standard System followed by end-to-end closure. Your tasks include Coordinating with Division and Service for product returns/investigation and closure of received complaints, Preparing 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 product & periodic review and updates of applicable SOP and Work instructions & responding to internal/external audits.

The ideal candidate will have a BS in Engineering, Science, or related degree; or MS in Regulatory Science, with 6-10 yrs experience in RA & quality. Responsibilities also include 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.



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