Cosmetic Compliance Consultant- Dental Whitening Products
Key Responsibilities:
1. Develop and lead global regulatory strategies for cosmetic and borderline products, ensuring alignment with FDA, EU MDR, and other international requirements.
2. Conduct comprehensive gap assessments against cosmetic, OTC, and product safety regulations; determine required technical documentation and assess existing files for deficiencies.
3. Prepare, review, and submit regulatory documentation, including PIFs, CPSRs, 510(k) submissions, PMAs, Technical Files, and Design Dossiers.
4. Create and manage remediation plans to close gaps in product documentation, regulatory submissions, and internal processes.
5. Evaluate regulatory impact of product, supplier, or process changes, conduct gap analyses, and coordinate necessary notifications or filings.
6. Lead audit readiness efforts, representing the organization during FDA inspections, Notified Body audits, and responding to CAPAs with robust documentation.
7. Review and approve labeling, IFUs, promotional materials, and packaging in accordance with 21 CFR Part 801, EU MDR Annex I, and cosmetic regulations.
8. Manage UDI compliance, EUDAMED submissions, PMS, vigilance reporting, and adverse event investigations per ISO 13485 and ISO 14971.
9. Act as primary liaison with FDA, Notified Bodies, and regulatory authorities; provide mentorship on regulatory intelligence and best practices.
Competency:
1. Proficient in MS Office, Excel Macros/VBA, PLM tools (e.g., Windchill), QMS platforms, and RegTech systems (MasterControl, RIMS); strong skills in Excel/SQL for data analysis and tracking.
2. Deep expertise in FDA, EU MDR/IVDR, ISO 13485, ISO 14971, regulatory intelligence, and risk management
3. Strong analytical aptitude, exceptional attention to detail, excellent stakeholder management, and advanced technical writing skills
Education/Experience:
1. Bachelor’s degree in Engineering, Regulatory Affairs, Biomedical Engineering, Life Sciences, Pharmacy, or related discipline (RAC certification preferred).
2. 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.
3. Proven ability to collaborate as a regulatory SME, delivering practical, customized compliance solutions.