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Job #03592

About our client Our client is a publicly traded biomedic company which is a global leader in the vision care and women's health industry. The organization has an experienced management team, a rich pipeline of development products, a world-class corporate culture and an established reputation for being a leading innovator in the field. Position Location Regulatory Affairs Specialist California Salary Highly competitive package, commensurate with experience Responsibilities 1) Prepare, review, compile and submit international regulatory filings 2) Participate in preparing international product registrations with in-country managers 3) Monitor and track information of individual country requirement changes 4) Maintain departmental databases and filing systems for regulatory submissions and related documents 5) Work independently on most assignments, utilizing information from multiple sources to solve moderately complex problems 6) Exercise independent judgment and decision-making on matters within standard company policies and regulatory requirements 7) Receive timely international product and or marketing approval for the International Department 8) Coordinate and prepare technical files/design dossiers for International Country Registrations (excluding European Union Medical Devices Directive CE mark requirements) 9) Supply samples, packaging, manufacturing site quality system certificates and Certificate of Free Sale, etc. in addition to the required technical documentation 10) Maintain and update the International Country Registration Database 11) Ensure accuracy and completeness of regulatory submissions, filings and tracking methods using standard programs and systems 12) Maintain regulatory library with copies of all country registration files and amend/update as necessary 13) Review initial product labeling and marketing materials to ensure compliance with the specific international country labeling requirements 14) Keep ahead of international regulatory requirements and changes within the regulatory registration process 15) Advise management on future international in-country regulations 16) Interact directly with government and regulatory agencies on specific issues 17) Review and advise on international product registration requirements, make recommendations to management regarding regulatory process and strategies 18) Identify issues or areas of concern and resolves routine problems Requirements 1) BA from a 4-year college or university 2) Minimum 5 years of regulatory affairs experience in the medical devices industry dealing with international country registrations 3) Experience in full-cycle submissions (i.e. PMA, 510K) 4) Experience in dealing with US and International Regulatory Bodies (FDA, EMEA, Asia, etc.)