Regulatory Affairs Specialist
Regulatory Affairs Specialist
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Job Description
Job Title: Regulatory Affairs Specialist.
Key responsibilities Duties:
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Experience with preparing design & development documentation including risk management to align with the regulatory strategy especially for class IIb devices.
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Experience for compilation of technical file/complete design dossier as per CE (EU MDR) ISO 13485 and USFDA guidelines.
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Experience in preparation of Device master file and other documents as per CDSCO MDR-17 requirements and submission of documents in CDSCO portal.
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Experience in preparation and submission of documents for Manufacturing licenses Import licenses and for the certificates for all Class of devices.
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Need to do documentation as per FDA & CE-MDR regulations and ISO standards. Perform audit compliances analysing gaps shortcomings as per FDA/ISO regulations.
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Understanding of cGMP regulations per 21 CFR and ISO 13485. Understanding of Risk Management per ISO 14971.
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Knowledge on post market surveillance PMCF clinical evaluation and UDI.
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Exposure to EU Medical Devices
Qualification:
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Technical writing
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English communication and teamwork.
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Detail oriented ability to read various standards and guidelines & define implementation details.
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Result oriented to develop and deliver components in a short span of time
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Has experience in individual working and had done the documentation work mentioned in the JD and has prior experience of technical file compilation and regulatory submissions for class IIB devices
Employment Type
Full Time
