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.