FIND YOUR DREAM JOB

Sign In
 [New User? Sign Up]
Mobile Version

RA Specialist / Sr. RA Specialist- S/W Regulatory


Source:
TIMESJOBS.COM
Location:
Gurugram, HR
Date:
09-11-2016
Job Code:
58237978
Categories:
  • Manufacturing & Production
Applying for this job will take you to an external site
  •  
  • Shortlist
  • Email Friend
  • Print

Job Details

Primary ResponsibilitiesSound 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).Responsible for generation and maintenance of software and device regulatory files.Partners with global and regional marketing in the development of regulatory plans for software and/ embedded Medical Devices.Interacts with global regulatory leaders in order to meet the expected deliverables.Informs affected groups of new and revised regulations, guidance and standards for software and medical devices that require changes in documentation.Provides training or presentations on software regulation, guidance and standards to cross-functional groupsDevelop and execute submission strategies for assigned projects. Monitor progress on key project deliverables and provide status updates on regular basis.Shall be knowledgeable on Interoperability, HL7 and DICOM.Expert-level knowledge of current industry standards for software engineering and risk management practices, ideally from the domain of safety critical applicationsDefine the regulatory strategy for medical device and associated submission strategy, including those devices containing a software component.Know the regulatory expectations for clearance/approval of medical device/combination products, including device software interfaces
Additional Degree: BE/ B.Tech (Engineering)

Experience: 4-8

Requirements

Application Programming | Business/Systems Analysis | Software Engineer | Systems Programming
Applying for this job will take you to an external site

FEATURED JOBS

© Copyright 2015 Al Nisr Publishing LLC - powered by Gulf News