Senior Director, Global Regulatory Lead – Devices, Regenerative Aesthetics

Hugel Aesthetics

Global regulatory leader guiding Hugel Aesthetics’ innovative medical device portfolio toward worldwide approvals. Shaping strategies, submissions, and health-authority engagement across the product lifecycle.

Posted 8/14/2026full-timeIrvine • California • 🇺🇸 United StatesSenior💰 $235,000 - $265,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates extensive expertise in global regulatory strategy for medical devices, particularly in the aesthetic market, with a strong focus on navigating complex regulatory pathways and engaging with health authorities. Proven ability to lead cross-functional teams and provide strategic oversight for regulatory submissions and compliance.

Highest-signal resume keywords

Global Regulatory Lead ExperienceMedical Device Regulatory StrategyInteraction With Global Health AuthoritiesRegulatory Approvals SuccessFluency In Korean

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Regulatory Strategy DevelopmentRegulatory SubmissionsRegulatory Due DiligenceClassification And Pathway GuidancePreclinical/Clinical StrategyCMC KnowledgeDesign ControlsGlobal Submission SequencingAesthetic Medical Device ExpertiseInjectables And Implants Experience

Soft Skills

Exceptional Communication SkillsNegotiation SkillsInterpersonal SkillsPresentation SkillsStrategic Oversight

Industry Keywords

Medical DeviceBiostimulatory ProductsRegenerative MedicineTissue-Related ProductsU.S. FDA RegulationsHealth CanadaKorean MFDSEuropean AuthoritiesNotified BodiesAesthetics Market

About the role

Key responsibilities & impact

Serve as Global Regulatory Lead for assigned medical device, biostimulatory, regenerative medicine, tissue-related, and other aesthetic development programs
Establish regulatory pathways from early R&D through the full product lifecycle
Develop and maintain integrated global regulatory strategies across the U.S., Korea, Europe, Canada, Australia, Asia-Pacific, and other priority markets
Identify regulatory opportunities, risks, and dependencies to influence product development and enterprise decision-making
Provide strategic oversight of major global submissions and lead resolution of significant deficiencies and health authority challenges
Represent Global Regulatory Affairs on cross-functional asset teams and governance committees
Translate complex health authority feedback into executive-level recommendations and practical mitigation options
Partner with R&D, Clinical, Medical, Safety, Quality, Manufacturing, Supply Chain, Commercial, Legal, and Business Development leaders
Provide regulatory guidance on classification and pathway, claims, preclinical/clinical strategy, CMC, design controls, and global submission sequencing
Lead face-to-face regulatory meetings and develop meeting strategy, including objectives, agency positions, negotiation approach, and desired outcomes
Lead or present interactions with the U.S. FDA, Korean MFDS, European authorities and notified bodies, Health Canada, and Australian TGA
Serve as senior regulatory expert for business development, licensing, acquisition, and partnership opportunities
Evaluate regulatory opportunities and risks associated with potential assets and prepare executive-level assessments and recommendations
Monitor evolving global regulatory requirements and facilitate alignment across Korea, the U.S., and regional regulatory organizations

Requirements

What you’ll need

Bachelor's degree in a scientific, engineering, biomedical, regulatory, or related discipline
Typically 12+ years of progressively responsible regulatory affairs experience, with substantial medical device industry experience
Significant experience leading regulatory strategy for aesthetic medical devices
Experience with injectables, implants, dermal fillers, biostimulatory products, regenerative medicine technologies, or tissue-related products preferred
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
Strong knowledge of U.S. FDA medical device regulatory requirements and international market strategy development
Substantial regulatory due diligence experience for licensing, acquisition, partnership, or investment opportunities
Fluency or professional proficiency in Korean strongly preferred
Exceptional written, verbal, presentation, negotiation, and interpersonal communication skills
Ability to travel up to 50%, including frequent travel to Korea

Benefits

Comp & perks

Base salary of $235,000 to $265,000 per year
Incentive compensation may be included in total cash compensation
Opportunity to travel internationally, including frequent travel to Korea