Regulatory Affairs Manager - (US-MA-Attleboro - 02703)

Minimum Education: None
Jobcode: L:98490850
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The Regulatory Affairs Manager for this established, yet highly innovative medical technology company will manage regulatory staff and activities for assigned projects and participate as a lead regulatory representative on core teams and develop and implement regulatory submission strategies. Requirements: Demonstrated success leading regulatory personnel in a dynamic medical device environment. Extensive and thorough knowledge of regulations/guidelines governing development of medical devices including Quality Systems requirements and the ability to mentor and guide others in the application of these principles. Demonstrated experience having primary responsibility for regulatory submissions, including successful FDA interface/negotiations. Expertise in development, review, and approval of labeling and promotional material. Must have knowledge of the U.S.A. Federal Regulations for medical devices including those applicable to the import/export of devices. Must have knowledge with the requirements for medical device registration/licensing in the EU, Japan, Canada, Australia, Latin America and Asia/Pacific. Must have exceptional written & oral communication skills and the ability to communicate appropriately with different engineering teams, Product Management, vendors and partners, and customers. Must be able to travel occasionally to meet with customers / project teams.   Education:  B.A./B.S. or advanced degree in scientific/life-sciences or engineering field with applicable industry experience and direct regulatory affairs experience with particular focus on U.S. FDA. Experience: 7+ years of relevant regulatory affairs experience, with at least 2 years in a supervisory role, leading direct reports in a regulatory function.  Additional competency and exposure in clinical affairs and clinical research planning is desired.