Works with International Product Managers to prioritize international product registrations and identify country specific regulatory requirements. Prepare and submit international regulatory submissions to support sales in key international markets. Interfacing with international country representatives, Notified Bodies and Representative for registrations and significant changes to products Release regulatory ship holds once approvals are obtained. Work with International Customer Service to resolve routine order, ship holds for international shipments. Maintain databases to ensure international regulatory requirements for new registrations as well as design changes are current and up to date. Work with distributors and international partners to assess design, process, labeling changes to determine impact on existing registrations. Submit CFG applications to FDA; FSC applications to State of CA FDB and international agencies as applicable global labeling requirements in order to ensure compliant implementation post approval
International regulatory requirements knowledge with a focus on China, Japan, Brazil, Mexico, Canada and MDD 93/42/EEC. Experience with Device registration on a global level Strong communication skills are a must
Regulatory Affairs Specialist • Carlsbad, CA, United States
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