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NeilMed Pharmaceuticals Inc

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Website      www.neilmed.com
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Regulatory Affairs Specialist

Experience: 8 to 10 yrs. Posted on: 07 Mar Develop and implement regulatory strategies. Implement quality system regulatory procedures and initiatives in to achieve compliance with FDA, ISO 13485:2003. Responsible for creation, preparation, and achievement of regulatory submissions and approvals to introduce new products in the US, EU, Canada, Australia and other markets, typically for Class I and II products and drugs (OTC and prescription as well). Coordinate and lead policies, processes, procedures, and controls ensuring that performance and quality of the products conform to established standards and agency guidelines. Provide leadership for quality system monitoring and improvements, and business process improvement initiatives. KEY RESPONSIBILITIES: Plan, coordinate and prepare document packages for regulatory submissions, including FDA 510(k), Technical Files, Canadian Device License Applications, and internal "Letters to File". Responsible for Regulatory Affairs submissions and on-going regulatory compliance for product development process. Prepare submissions to gain approvals for clinical research, export, and commercial distribution for device and other products. Responsible for foreign registrations and "Permission to Export" documents. Maintain submission correspondence files and other regulatory files in a complete and secure manner. Maintain annual facility registration and device-listing documents. Ensure that existing approvals and documentation are maintained. Review device labeling and advertising materials for compliance with global regulations; analyze and recommend appropriate changes. Review and sign off on product and manufacturing changes for compliance with applicable regulations. Review and approve regulatory submissions and approvals, including design and manufacturing changes, labeling, web page content, and advertisements. Provide regulatory input in quality system assessments, product development, and complaint/MDR/Vigilance handling system. Review and approve test protocols to support regulatory submissions. Provide input on and review Design Control documentation such as: Risk Management, design verification, design validation, shelf life studies. Initiate, follow-up, negotiate, and resolve issues regarding current and future submissions, under minimal direction, up to and including travel to, and direct discussions with the appropriate regulatory agency. Develop and implement departmental and divisional policies and procedures. Other duties as assigned. Education: (UG - Any Graduate - Any Specialization) AND (PG - Post Graduation Not Required) AND ( Doctorate - Doctorate Not Required)

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