Jobs in Irvine, CA

About the role

This role is ideal for someone who thrives in a fast-paced, entrepreneurial environment, embraces ambiguity, and is energized by the opportunity to build, contribute, and grow alongside a team that is creating something special. This is a highly visible, enterprise-level role for someone who wants to represent Global Regulatory Affairs on cross-functional asset teams, engage directly with global health authorities and notified bodies, and bring clear, actionable recommendations to senior leadership and governance committees.

What you'll bring

• Bachelor's degree in a scientific, engineering, biomedical, regulatory, or related discipline
• Typically 12+ years of progressively responsible regulatory affairs experience, with substantial experience in the medical device industry.
• Significant experience leading regulatory strategy for aesthetic medical devices
• Demonstrated experience functioning as a Global Regulatory Lead or equivalent strategic regulatory leader for development-stage and marketed products.
• Extensive direct experience interacting with global health authorities and notified bodies, including leading and presenting during face-to-face regulatory meetings.
• Proven and recent success obtaining regulatory approvals for medical devices in the global aesthetics market, with meaningful personal leadership of the strategy and approval process.
• Strong knowledge of U.S. FDA medical device regulatory requirements and experience developing strategies for international markets.
• Substantial regulatory due diligence experience, including evaluation of licensing, acquisition, partnership, or investment opportunities.
• Exceptional written, verbal, presentation, negotiation, and interpersonal communication skills.
• Ability to travel up to 50%, including frequent travel to Korea.
• Fluency or professional proficiency in Korean is strongly preferred and would be a significant advantage.
• advanced degree preferred.