Cosmetic Compliance Consultant- Dental Whitening Products

Cosmetic Compliance Consultant
- Dental Whitening Products Key Responsibilities

• Develop and lead global regulatory strategies for cosmetic and borderline products, ensuring alignment with FDA, EU MDR, and other international requirements.
• Conduct comprehensive gap assessments against cosmetic, OTC, and product safety regulations; determine required technical documentation and assess existing files for deficiencies.
• Prepare, review, and submit regulatory documentation, including PIFs, CPSRs, 510(k) submissions, PMAs, Technical Files, and Design Dossiers.
• Create and manage remediation plans to close gaps in product documentation, regulatory submissions, and internal processes.
• Evaluate regulatory impact of product, supplier, or process changes, conduct gap analyses, and coordinate necessary notifications or filings.
• Lead audit readiness efforts, representing the organization during FDA inspections, Notified Body audits, and responding to CAPAs with robust documentation.
• Review and approve labeling, IFUs, promotional materials, and packaging in accordance with 21 CFR Part 801, EU MDR Annex I, and cosmetic regulations.
• Manage UDI compliance, EUDAMED submissions, PMS, vigilance reporting, and adverse event investigations per ISO 13485 and ISO 14971.
• Act as primary liaison with FDA, Notified Bodies, and regulatory authorities; provide mentorship on regulatory intelligence and best practices.

• Proficient in MS Office, Excel Macros/VBA, PLM tools (e.g., Windchill), QMS platforms, and Reg Tech systems (Master Control, RIMS); strong skills in Excel/SQL for data analysis and tracking.
• Deep expertise in FDA, EU MDR/IVDR, ISO 13485, ISO 14971, regulatory intelligence, and risk management.
• Strong analytical aptitude, exceptional attention to detail, excellent stakeholder management, and advanced technical writing skills.

• Bachelor’s degree in Engineering, Regulatory Affairs, Biomedical Engineering, Life Sciences, Pharmacy, or related discipline (RAC certification preferred).
• 8+ years of experience in cosmetic compliance with hands‑on experience in dental/whitening products, borderline classifications, OTC/GPSR, safety reports, PIFs, safety assessments, and international regulatory requirements.
• Proven ability to collaborate as a regulatory SME, delivering practical, customized compliance solutions.