Job Id
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181102
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Title
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Regulatory Specialist
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Job Type
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Permanent
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Duration
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City
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Hyderabad
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State
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Telangana
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Zip
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Job Description
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• Write business proposals with complete analysis of the requirements, providing regulatory approach. • To support the Regulatory compliance - gap analysis and remediation of the dossiers. • To understand and support for the QMS services as per ISO 13485/21 CFR part 820. • To understand classification of Medical devices as per Medical Device Rules 2017and assist in the identification of potential product technical file and/or clinical report improvements • To understand EU classification of the product, CE Marking procedure and compilation and review of the MDR/MDD and IVDR/IVDD technical files for EU markets. • To evaluate the product classification in-line with US-FDA and Global requirements and support the preparation/compilation, review and finalize the regulatory submissions as per regulatory requirements. • To understand and have knowledge on the implementation of the Risk Management File, Plan and Procedures as per ISO 14971. • Risk Management Reports writing as per ISO 14971. • Usability Engineering Reports writing as per ISO 62366. • Follow Quality System procedures to ensure compliance with 21 CFR 820, ISO 13485, MDD/MDR, AIMD for regulatory compliance in alignment with client objectives. • Interpret and communicate regulatory changes to ensure the client is aware of opportunities, risks and issues while being responsible for ensuring compliance with the regulations and client’s processes and procedures.
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Qualification
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Certification/Licensure
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Experience
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2-5yrs
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Job Category
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Regulatory Affairs
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Posted On
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11/14/2018
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Expires On
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3/14/2019
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