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Senior Regulatory Affairs Specialist

Company: Mouchel
Location: Minneapolis
Posted on: June 16, 2019

Job Description:

Job Details - Smiths Medical * Contact Us * Regional Sites * News & Events * Webstore * Careers * Log in / Create Profile EnglishDeutschFranaisItalianoetinaEspaol * Products * Area of care * Brands * Resource Center * Company Information * Customer Support Menu * Jobs and Careers * Job Details Job Details * Job Search * Save Search Senior Regulatory Affairs Specialist Location North America, USA, Minnesota, Minneapolis Job Reference MEDNA00126 Job Description This position provides regulatory expertise for the site and will also be required to provide regulatory advice and assistance to other Smiths Medical site representatives. Prepare and submit regulatory submissions to Regulatory Authorities e.g. the FDA, (for PMAA, IDE, 510(k) Notification); and to European notified body to support distribution and marketing objective set by divisional and corporate staff. This will require travel from time to time to effectively carry out these duties. Duties & Responsibilities * Prepare and submit 510(k) Premarket Notification, PMA, IDE, and Design Dossier submissions as directed * Ensure regulatory compliance to FDA and international regulations. * Create and maintain Essential Requirements Checklists, CE Technical Files and Declarations of Conformity for all products bearing the CE Marking. * Prepare Annual PMA Report and associated PMA Supplements as required. * Regulatory representative on new product development teams. * Review and approve ECO's for product changes and/or modifications related to manufacturability and/or material modifications. Ensure compliance to existing regulatory submissions. * Review and approve technical literature (labeling, IFU's, manuals, patient guides, etc.), sales and marketing literature, and reimbursement literature related to company products. * Review and approve Pre-launch product submissions to ensure compliance with internal company requirements and compliance with regulatory requirements. * Review and provide oversight of FDA Drug Listings, State Distributor Licensing among State Boards of Pharmacy, and Global Product Registration in support of Direct Reports. * Keep abreast of new and changing regulatory requirements. * Update RA procedures as needed to ensure Smiths Medical is in compliance with new and changing regulatory requirements. * Inform project teams of new and changing regulatory requirements. * This position is required to assure compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including but not limited to FDA, Quality Systems Regulations, ISO 13485, ISO 14001, government occupational health and environmental regulations and statutes). * Engage others, promote, and participate in Environmental, Health, and Safety initiatives, focusing on continuous improvement * Review and approve engineering change orders (ECO's) ensuring compliance with FDA and international submissions on file. * Provide regulatory guidance on new product development and manufacturing changes to existing products. * Review and approve Pre-launch product submissions to ensure compliance with internal company requirements and compliance with regulatory requirements. * Review and approve product literature to ensure compliance with FDA and international submissions on file. * Direct the development of international master files for registration of product in international markets. * Engage others, promote, and participate in Environmental, Health, and Safety initiatives, focusing on continuous improvement. * This position is required to assure compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including knowledge of all standards, government occupational health and environmental regulations and statutes related to the site). The Individual Technical Knowledge and Skills: * Bachelor's degree in Science or Engineering (or related field) from an accredited college or university. A minimum of Seven to ten years direct experience in quality/regulatory affairs (preferably in the medical device/drug or biomedical area). * Excellent verbal, written, and presentation communication skills. * Proven effective leadership skills to guide, mentor, and develop staff members to perform under stress to meet or exceed project schedules and corporate filing deadlines. * Effective facilitation skills to motivate engineers, marketing personnel and/or clinical staff to deliver information related to submission preparation and/or direct product literature review, both technical and sales marketing pieces. * Knowledge and ability to develop, review and approve technical literature as it relates to product specifications and that is consistent with domestic and international regulations. * Sound knowledge and understanding of company products as they relate to medical device law and international medical devise requirements. * Knowledge and ability to review and approve ECO's and corporate SOP's. * Sound knowledge and understanding of how IDE regulated clinical studies are performed. * Excellent working knowledge of up-to-date domestic, international, and company regulatory compliance requirements and operating procedures. Including but not limited to FDA, PMAA, IDE, 510(k) Notifications, Medical Device Directive, and European Standards. Abilities: * Ability to arbitrate conflicts between departments regarding quality and regulatory issues. * Ability to influence and lead department members and peers as well as work effectively as a team player. * Ability to develop and implement short and long range department goals in reference to Regulatory Affairs. * Ability to analytically assimilate regulatory information and updates and effectively convey these principals to appropriate departments. * Ability to negotiate critical points regarding devices to the favor of corporate objectives, (i.e. to reduce costs associated with regulation and/or marketing objectives). About Us Smiths is always looking for curious minds. For new colleagues who want responsibility and relish a challenge. Those who would like to use their talents to help make the world safer, healthier, more efficient and more connected. We're proud that we've been helping propel the human world forwards during our 160 year history of innovation. By looking at things differently. By adapting and never standing still. And by always thinking big. Today we're an aligned global business of five divisions and around 22,000 colleagues, that touches the lives of millions every year across five vibrant global markets. In Smiths Medical, one of the five divisions of Smiths Group, we touch the lives of millions of people every day. Our colleagues are focused on providing innovative, lifesaving solutions for patients around the world. So whether you're an experienced professional or just starting out on your career, our global scale and focus on growth means great career opportunities for the right colleagues. There's never been a better time to join Smiths. And help us create the future. Apply Now Apply with LinkedIn Back * Brands * BCI * CADD * Deltec * Graseby * Jelco * Level 1 * Medex * Medfusion * Pneupac * Portex * Surgivet * Wallace * Products * Airway Management * Assisted Reproduction * Drainage Systems * Infusion * Interventional Imaging * Pain Management * Patient Monitoring * Pressure Monitoring * Respiratory * Sharps Safety * Temperature Management * Tracheostomy * Customer Support * Contact Us * Continuing Education * Distributor List * Company Information * Corporate Responsibility * Executive Team * News and Events * History of Smiths Medical * Specialty Areas Smiths Medical is part of the global technology business Smiths Group plc. Product(s) described may not be licensed or available for sale in all countries. BCI, CADD, Deltec, Graseby, Jelco, Level 1, Medex, Medfusion, Pneupac, Portex, Surgivet, Wallace, Smiths Medical and all corresponding design marks are trademarks of Smiths Medical. The symbol indicates the trademark is registered in the U.S. Patent and Trademark Office and certain other countries. All other names and marks mentioned are the trade names, trademarks or service marks of their respective owners. Please see the Instructions for Use for a complete listing of the indications, contraindications, warnings and precautions. * Legal Notice * Terms and conditions * Cookie policy * Ca legal information * MRI compatibility * Professional organisations Copyright 2019 - All rights reserved. Close * Products * Area of care * Brands * Resource Center * Company Information * Customer Support Career Navigation * Job Search * Save Search

Keywords: Mouchel, Minneapolis , Senior Regulatory Affairs Specialist, Other , Minneapolis, Minnesota

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