Global Regulatory Strategy Lead – Biologics & Devices (Hybrid)

Smith+Naphew is seeking a Director of Regulatory Affairs for the Advanced Wound Bioactives portfolio in a hybrid role. You will lead global regulatory strategies, mentor a two-site team (Fort Worth, TX and Columbia, MD), and drive 510(k), BLA/sBLA submissions and Health Canada approvals. The role requires a minimum of ten years of regulatory experience, deep FDA expertise, and a track record of strategic, cross-functional collaboration across biologics, HCT/Ps and device-led combinations.