Cosmetic Compliance Consultant- Dental Whitening Products

Cyient

Seattle (WA)

On-site

USD 100,000 - 130,000

Full time

14 days+

Application generator

Get a reply from this employer — a resume and cover letter tailored to exactly what they’re hiring for.

Get past ATS filters

Job summary

A leading compliance consultancy seeks a Cosmetic Compliance Consultant for dental whitening products. You will develop and lead global strategies, conduct gap assessments, prepare regulatory documentation, and act as a liaison with regulatory authorities. Required qualifications include a degree in a relevant field and 8+ years of experience in cosmetic compliance. Strong skills in MS Office, regulatory knowledge, and attention to detail are essential for success in this role.

Qualifications

Bachelor’s degree in Engineering or Life Sciences required.
8+ years of experience in cosmetic compliance, ideally in dental products.
RAC certification preferred.
Proven ability to collaborate as a regulatory SME.

Responsibilities

Develop and lead global regulatory strategies for cosmetic products.
Conduct comprehensive gap assessments for compliance.
Prepare and submit regulatory documentation including PIFs and 510(k) submissions.
Lead audit readiness efforts and represent the organization during inspections.

Skills

Proficient in MS Office and Excel Macros/VBA

Strong skills in Excel/SQL for data analysis

Deep expertise in FDA and EU regulations

Exceptional attention to detail

Advanced technical writing skills

Education

Bachelor’s degree in a related discipline

Tools

RegTech systems (e.g., MasterControl, RIMS)

PLM tools (e.g., Windchill)

Job description

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.

Competency

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.
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.

Education/Experience

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.

Get your free, confidential resume review.

or drag and drop your file here.