Sr. Regulatory Affairs Specialist, Medical Devices (Long Beach, CA)
About The Position
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 devices. Supports regulatory strategy and compliance activities for HydraFacial’s aesthetic medical devices and professional systems throughout the product lifecycle. This includes developing regulatory planning, 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.
Requirements
- 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.
Nice To Haves
- Working knowledge of international regulations in the EU MDR and APAC regions.
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.
Benefits
- 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)
- paid holidays
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What This Job Offers
Job Type
Full-time
Career Level
Senior
