Director Regulatory Affairs

Director of Regulatory A leading global diagnostics company is seeking a Director of Regulatory Affairs for their growing team. The Director of Regulatory Affairs will lead a product life cycle group and ensure the timely approvals and clearances of diagnostics products in theU.S., EU, and international markets. Responsibilities: - Directors regulatory responsibilities associated with the development, support, and manufacturing of the Company's diagnostic products. - Directs and develops regulatory strategies and plans to for timely approval of new products - Collaborate with external partners to support common regulatory and quality initiatives. - Provide review and approval of product labeling and promotional materials to ensure compliance with local applicable regulations. - Provide cost and timelines estimates in support of regulatory/quality strategies - Manages filing and submissions of 510(k), PMA and/or International registrations - HR function for hiring, interviewing, performance feedback, etc. for direct reports and providing regular reporting to management on regulatory metrics. - ImplementingUSAstrategies as well as coordinate with international regulatory team to implement global registrations. - Monitors and assesses Regulatory developments related to the Company's products. Qualifications: - 8+ Years Regulatory Affairs Experience - Hands-on submissions experience with IVD or class II/III medical device company - Experience with 510(k), PMA and/or BLA and/or International Registrations - Proven success working with FDA; clearances / approvals of medical devices, diagnostic or pharmaceuticals. - Must be collaborative and work well in team settings - Must have strong communication skills, both verbally and written - Bachelor's Degree (Life sciences or Engineering strongly preferred)

To find out more about Real please visit www.realstaffing.com [1]

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[1] http://www.realstaffing.com