Associate Director, Regulatory Affairs US & Canada Strategy Lead – Facial Aesthetics - Device

📋 Description Develop and implement US/Canada regulatory strategy and RSTP for assigned products. Lead lifecycle activities: changes, post-approval, Health Authority requests, reporting. Manage FDA interface; coordinate meetings and briefing packages. Advise cross-functional teams on regulatory/FDA issues. Coordinate regulatory submissions and ensure timely responses. Mentor junior staff and provide regulatory guidance. 🎯 Requirements Advanced degree (PhD/PharmD/MS) or regulatory cert with 7+ years in regulatory/R&D. Strong written and verbal communication within Regulatory and cross-functional teams. Extensive experience interfacing with government agencies and Health Authorities. Ability to deliver tough messages without harming business relationships. Experience in complex, matrixed environments; negotiation skills. Experience implementing affiliate regulatory strategies for US/Canada devices. US Class III device experience; familiarity with manufacturing/change control. Strategic, forward-looking regulatory experience to accelerate programs. 🎁 Benefits Comprehensive benefits including PTO, medical/dental/vision, and 401(k). Eligible to participate in long-term incentive programs. Equal opportunity employer; commitment to integrity and diversity.