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RA Specialist /Sr. Regulatory Affairs Specialist- Software

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  • IT
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Job Details

Roles and ResponsibilitiesThe Senior Regulatory Affairs Specialist provides guidance to project teams during design and development of software and instrumentation products and prepares related documentation for global regulatory submissions. Provides regulatory guidance for system integrations. Performs regulatory reviews for proposed software and device changes to determine impact on existing registrations. Monitors regulations, guidance and standards pertaining to MDD and software and informs affected groups of needed changes.Primary Responsibilitieso Sound knowledge of IEC 62304 Medical device Software Software life cycle processes. This also includes good exposure to all the phases of Software development life cycle (SDLC).o Responsible for generation and maintenance of software and device regulatory files.o Partners with global and regional marketing in the development of regulatory plans for software and/ embedded Medical Devices.o Interacts with global regulatory leaders in order to meet the expected deliverables.o Informs affected groups of new and revised regulations, guidance and standards for software and medical devices that require changes in documentation.o Provides training or presentations on software regulation, guidance and standards to cross-functional groupso Develop and execute submission strategies for assigned projects. Monitor progress on key project deliverables and provide status updates on regular basis.o Shall be knowledgeable on Interoperability, HL7 and DICOM.o Expert-level knowledge of current industry standards for software engineering and risk management practices, ideally from the domain of safety critical applicationso Define the regulatory strategy for medical device and associated submission strategy, including those devices containing a software component.o Know the regulatory expectations for clearance/approval of medical device/combination products, including device software interfaces
Degree: M.Com. (Commerce) | M.Pharm. (Pharmacy) | M.Sc. (Science) | MA (Arts) | MBA/ PGDM | MCA/ PGDCA

Additional Degree: BE/ B.Tech (Engineering)

Experience: 4-8


Software Engineer | System Administration | System Analyst/Tech Architect
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