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The genomics division designs and develops state of the art, cutting edge, genetic testing IVD products. As a regulatory affairs specialist, you would participate as a team member on exciting projects related to Next Generation Sequencing, PCR Instrument, Microarray Scanner, Reagents and Variant Calling software for variety of applications like singe cell analysis, post-natal, and oncology

Job tasks may include but not be limited to:

• Ensure that for all product regulatory requirements are met throughout the development process as per FDA QSR, ISO 13485, Health Canada, China FDA, Japan PMDA and Rest of the world regulations
• Lead and assist in migration of self-certified CE-IVD regulated products to EU IVDR
• Create and maintain product 510(k), EU technical, Health Canada, China FDA, Japan PMDA and country specific regulatory submission files
• Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners, advise on the submission strategy. Responsible for product submissions, facility listing, product registrations, and license renewals with regulatory agencies.
• Organize regulatory information and track and control submissions, review and advise on labeling for compliance with regulatory filings
• Actively participate in evaluation of regulatory compliance of document / product /process / test methods changes.
• Review product changes for impact on regulatory filings worldwide, and research regulatory issues and provide guidance and advice to colleagues. Author regulatory plan for genomics products.
• Maintain regulatory files/database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted to agencies or partners
• Review advertising and marketing material for appropriateness and compliance to regulatory requirements and laws
• Conduct regulatory reviews of customer complaints and report to regulatory agencies.
• Maintain current knowledge of FDA QSR, ISO 13485, EU, China, Japan and other international regulation, guidance and standards applicable to company IVD and medical device products
• Participate in research of regulatory issues and dissemination regulatory information to Production, QA, QC and R&D departments and senior management as required. Supervise regulatory consultants