Regulatory Affairs and Quality Assurance Specialist

The Offer

• Work alongside & learn from best in class talent
• A role that offers a breadth of learning opportunities
• Flexible working options

The Job What You’ll Do Regulatory Compliance & FDA Oversight

• Ensure all products meet international skincare regulations by managing product registrations and maintaining compliance documentation.
• Lead the charge on FDA oversight, ensuring products align with OTC and cosmetic standards.

Product Testing & Claims Validation

• Oversee clinical and stability testing to validate product claims and determine the need for long-term studies.
• Guarantee that all product claims are scientifically substantiated.

International Compliance & Market Entry

• Manage global regulatory requirements, including ingredient restrictions, packaging guidelines, and product classification, to facilitate smooth international expansion.
• Stay ahead of the curve with market-specific regulations to streamline entry into new regions.

CMO & R&D Coordination

• Collaborate with contract manufacturers (CMOs) and R&D teams to ensure formulations align with regulatory standards.
• Drive production feasibility, supplier negotiations, and ensure seamless alignment between innovation and compliance.

Ingredient Reformulation & Compliance

• Evaluate regulatory implications for reformulated products, ensuring ongoing compliance with OTC regulations and market standards.

Product Ownership & IP Management

• Maintain meticulous records of formulations, testing protocols, and product registrations to secure seamless manufacturer transitions and safeguard intellectual property.

Adverse Reaction & Quality Complaints Management

• Manage and track adverse reactions reported by users, ensuring timely reporting and appropriate regulatory responses.
• Oversee the resolution of quality complaints and implement improvements to prevent future issues.

Batch Record Management

• Handle batch record reviews to ensure manufacturing processes meet regulatory and quality standards.
• Maintain accurate and thorough records to ensure compliance and facilitate smooth audits.

Education & Sales Support (Preferred)

• Use your dermatology or aesthetics background (if applicable) to support training, sales education, and client account management.

The Profile What You Bring

• Proven Expertise : Extensive experience in regulatory affairs and quality assurance within the medical skincare or cosmetics industry.
• Knowledge of Regulations : Deep understanding of FDA, OTC, and international cosmetic/skincare compliance standards.
• Scientific Excellence : Expertise in formulation compliance, product testing, and stability studies to validate claims.
• Global Mindset : Ability to manage international compliance, ingredient substitutions, and regulatory documentation for global markets.
• Adverse Reaction Management : Familiarity with managing and reporting adverse reactions in compliance with regulatory requirements.
• Exceptional Communication : Strong English communication skills (written and verbal) for seamless collaboration with cross-functional teams.
• Preferred : Background in medical skincare or professional aesthetics/dermatology to enhance sales and education initiatives.

Ready to bring your expertise in regulatory affairs and quality assurance to a premium skincare leader? Apply today and help shape the future of this extraordinary brand—all while working remotely! The Employer Are you a compliance-driven professional with expertise in skincare regulations and a passion for innovation? Join a premium medical skincare brand that has been shaping the industry for over 30 years. As a Regulatory Affairs and Quality Assurance Specialist , you’ll play a critical role in ensuring regulatory excellence, driving product compliance, and supporting global expansion—all from the comfort of your home. About the Company This established and fast-growing skincare brand is renowned for delivering premium, science-backed products. With a strong commitment to global expansion, they are seeking a talented individual to lead compliance initiatives, oversee FDA and international regulations, and ensure their premium reputation in the skincare industry remains unparalleled.