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Smith & Nephew

Director, Regulatory Affairs – Biologics & Devices (Hybrid)

fort worth, TX

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About this opportunity

Smith & Nephew lists this Director, Regulatory Affairs – Biologics & Devices (Hybrid) opportunity in fort worth, Texas. Review the employer’s description below for duties, qualifications and application requirements.

Job description

Smith+Naphew is seeking a Director of Regulatory Affairs to lead the Wound portfolio's regulatory strategy and manage a cross-functional team across Fort Worth, TX and Columbia, MD. The role focuses on securing timely approvals for 510(k), BLA/sBLA, and HCT/P submissions while ensuring compliance with global regulations.

Requires a minimum of a Bachelor's degree and 10+ years of regulatory experience, with proven capability in FDA submissions, international filings, and strong leadership and

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Worksite address

fort worth, TX, 76102, US

Who can apply

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