Sr. Regulatory Affairs Specialist, Medical Devices

About the role

The Senior Regulatory Affairs Specialist for Medical Devices is a key contributor in bringing the company's products into new markets and supporting new launches and existing medical device s. S upports regulatory strategy and compliance activities for HydraFacial's aesthetic medical devices and professional systems throughout the product lifecycle.

This includes develop ing regulatory plan ning, preparing submissions, ensuring ongoing compliance with applicable regulations such as U.S. FDA and international market regulations, and supporting cross-functional teams to bring innovative solutions to market safely and efficiently.

Primary Responsibilities

• Support product registrations (APAC, Canada, U.S., LATAM) and related regulatory activities, ensuring new or updated requirements are effectively 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 (including HydraFacial and related systems), ensuring alignment with business goals.
• Review and update Declarations of Conformity (DOC) to meet applicable regulatory standards and country requirements with manager supervision.
• Draft and coordinate preparation of technical documentation & dossiers for regulatory authorities.
• Prepare for and participate in audits/inspections and help respond to regulatory inquiries or findings.
• Review device design changes and product labelling 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 on a regular basis with manager supervision.
• Review labelling changes, translation requirements, and provide regulatory support for updates as required.
• Additional duties assigned by management.

What you need to know

Required

• 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

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

We mean it when we say you'll LOVE this role.

Base Pay

$107,500 - $125,000 + Bonus

Working model: Hybrid

An employee's pay position within the salary range will be based on several factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, seniority, geographic location, performance, travel requirements, revenue-based metrics, any contractual agreements, and business or organizational needs. The range listed is just one component of Hydrafacial's total rewards package for our employees. Other rewards may include annual bonuses, long-term incentives based on level, paid time off, and region-specific benefits. Come grow and GLOW with us!

Perks!

Benefits include: Medical insurance, dental insurance, vision insurance, FSAs, 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.

Hydrafacial does not accept unsolicited assistance or resumes/CVs from third party search firms. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral or CV/resume submitted by a search firm to any employee at our company without a valid written search agreement. If we need additional support, we will be sure to reach out directly to one of our preferred providers. Please no phone calls or emails.