Senior Director Global Regulatory Lead Devices & Regenerative Aesthetics

About Hugel Founded in 2001, Hugel is a South Korea–based global leader in medical aesthetics, specializing in the development and commercialization of botulinum toxin, hyaluronic acid fillers, skin boosters, threads, and biocosmetics. Over the past two decades, Hugel has built a strong global footprint, with commercial presence in approximately 70 countries and operations across nine international subsidiaries. Leveraging strong global momentum, Hugel Aesthetics was formed as the Company's dedicated North American business unit, established to lead commercialization in the United States, Canada, and Australia. Backed by Hugel's global scale and expertise, Hugel Aesthetics is a well-resourced, growth-oriented organization focused on expanding access to Letybo and establishing a strong, long-term presence in medical aesthetics. Company Culture We are building our U.S. organization from the ground up, creating a culture that is intentionally different from traditional, highly layered companies. This is a rare opportunity to join at an early stage and help shape not only the business, but the way we work, lead, and grow together. Our culture is rooted in high ownership, collaboration, and the belief that every voice matters. We value people who bring ideas, take initiative, and want a true seat at the table. In this environment, individuals are empowered to make an impact, move with agility, and help build what comes next. Above all, we are deeply customer focused. We are committed to earning trust, building long-term partnerships, and delivering meaningful value through science, transparency, and integrity. 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. About This Role The Senior Director, Global Regulatory Lead (GRL) — Devices & Regenerative Aesthetics will serve as the global regulatory strategic leader for Hugel's medical device portfolio, with emphasis on biostimulatory, regenerative medicine, tissue-related, combination/novel technology, and other innovative aesthetic products. You will develop, maintain, and execute integrated global regulatory strategies across the full product lifecycle — from early development and business development due diligence through registration, commercialization, and lifecycle management. You will partner closely with R&D and cross-functional teams in the U.S., Korea, and additional global markets, with frequent travel to Korea to support pipeline programs and health authority preparation. 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 Will Do Global Regulatory Strategy & Lifecycle Management Serve as Global Regulatory Lead for assigned medical device, biostimulatory, regenerative medicine, tissue-related, and other aesthetic development programs, establishing regulatory pathways from early R&D through the full product lifecycle. Develop and maintain an integrated global regulatory strategy across the U.S., Korea, Europe, Canada, Australia, Asia-Pacific, and other priority markets. Identify regulatory opportunities, risks, and dependencies early enough to influence product development and enterprise decision-making. Provide regulatory leadership for novel technologies where classification, jurisdiction, or development pathways are not well established. Provide strategic oversight of major global submissions and lead resolution of significant deficiencies and health authority challenges. Governance & Enterprise Decision-Making Serve as the regulatory representative and strategic advisor on cross-functional asset teams and governance committees. Translate complex health authority feedback into concise, executive-level recommendations, escalating significant risks with practical mitigation options. Partner with senior leaders across R&D, Clinical, Medical, Safety, Quality, Manufacturing, Supply Chain, Commercial, Legal, and Business Development. R&D and Product Development Partnership Serve as strategic regulatory partner to R&D teams in Korea and the U.S. from concept through commercialization, traveling frequently to Korea to support development planning and project reviews. Provide regulatory guidance across the product lifecycle, including classification and pathway, claims, preclinical/clinical strategy, CMC, design controls, and global submission sequencing. Global Health Authority & Notified Body Engagement Lead face-to-face regulatory meetings and develop meeting strategy — objectives, anticipated agency positions, negotiation approach, and desired outcomes. Lead or present directly during interactions with agencies such as the U.S. FDA, Korean MFDS, European authorities and notified bodies, Health Canada, and Australian TGA. Translate health authority feedback into clear implications for strategy, timelines, and investment decisions. Business Development & Due Diligence Serve as senior regulatory expert for business development, licensing, acquisition, and partnership opportunities. Independently evaluate regulatory opportunities and risks associated with potential assets and convert findings into executive-level risk assessments and recommendations. Regulatory Intelligence & Cross-Functional Collaboration Maintain strong awareness of evolving global regulatory requirements affecting medical devices and emerging aesthetic platforms. Build strong relationships across geographically and culturally diverse teams, facilitating alignment between Korea, U.S., and regional regulatory organizations. What We Are Looking For Bachelor's degree in a scientific, engineering, biomedical, regulatory, or related discipline; advanced degree preferred. 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, preferably including injectables, implants, dermal fillers, biostimulatory products, regenerative medicine technologies, or tissue-related products. 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. Fluency or professional proficiency in Korean is strongly preferred and would be a significant advantage. Exceptional written, verbal, presentation, negotiation, and interpersonal communication skills. Ability to travel up to 50%, including frequent travel to Korea. Compensation: The most likely base pay range for this position is $235,000 to $265,000 per year. Several factors, such as experience, tenure, skills, and particular business needs, will determine an individual’s exact level of compensation. Base salary is only one element of employee compensation at Hugel Aesthetics. The total cash compensation could include base salary and incentive compensation. Location This is an on-site role based in Irvine, CA.