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About the Role

Senior Regulatory Affairs Specialist for Medical Devices – key contributor in bringing HydraFacial’s aesthetic medical devices and professional systems into new markets and supporting new launches and existing devices throughout the product lifecycle.

Key Responsibilities

• Support product registrations (APAC, Canada, U.S., LATAM) and related regulatory activities, ensuring new or updated requirements are communicated to relevant departments.
• Provide regulatory input into Standard Operating Procedures (SOPs) for manufacturing activities, design and risk assessments.
• Implement and execute regulatory strategies for assigned medical device products, ensuring alignment with business goals.
• Review and update Declarations of Conformity (DOC) to meet applicable regulatory standards and country requirements under manager supervision.
• Draft and coordinate preparation of technical documentation and dossiers for regulatory authorities.
• Prepare for and participate in audits/inspections and respond to regulatory inquiries or findings.
• Review device design changes and product labeling for regulatory impact and compliance.
• Provide regulatory support and communication cross‑functionally regarding product development, design reviews, risk assessments, and regulatory intelligence.
• Update device technical files, DHF, GSPR, essential checklists, product registrations, master product catalogue, and workload trackers regularly under manager supervision.
• Review labeling changes, translation requirements, and provide regulatory support for updates as required.
• Additional duties assigned by management.

Required Qualifications

• 5–7 years direct experience in a Regulatory Affairs role in a medical device or aesthetic device industry.
• Bachelor’s degree in a science‑related field or equivalent.
• Familiarity with ISO 13485 and other quality system standards.
• Experience with FDA device regulations and submission processes (e.g., 510(k) pathways).
• Excellent technical writing skills and knowledge of submission/dossier documents.
• Ability to work in a fast‑paced environment managing multiple projects.
• Strong regulatory strategy development and problem‑solving skills.
• Ability to interpret regulations, assess impact, and propose compliant solutions.
• Detail‑oriented with excellent organizational skills.
• Effective team player with the ability to influence cross‑functional groups.

Desired Qualifications

• Working knowledge of international regulations in the EU MDR and APAC regions.

Compensation and Working Model

Base Pay: $107,500–$125,000 + Bonus. Working model: Hybrid.

Benefits

• Medical, dental, and vision insurance
• FSAs and HSAs
• Accident insurance
• Pet insurance
• Company‑paid life and AD&D insurance
• Company‑paid long‑term and short‑term disability insurance
• 401(k) with employer match
• Paid time off (PTO) and paid holidays
• Other rewards may include annual bonuses and long‑term incentives based on level

Equal Employment Opportunity

Hydrafacial is proud to be an equal opportunity employer. We prohibit discrimination and harassment of any kind based on race, sex, religion, sexual orientation, national origin, gender identity, gender expression, age, disability, genetic information, pregnancy, or any other protected characteristic as outlined by color, federal, state or local laws. We are committed to working with and providing accommodation to applicants with physical and mental disabilities.