Beauty Health

Beauty Health

Sr. Regulatory Affairs Specialist, Medical Devices (Long Beach, CA)

USA, California - Long Beach · Senior

Sponsorship not specified$108k-$125kDetected 9 days ago
Computer VisionProduct ManagementFDA RegulatoryMedical DevicesCommunicationProblem SolvingWritingRegulatory Affairs

About the role

  • Every person here is a key player in our success.
  • If this sounds like you, come check us out!
  • Job Description: 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.

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.
  • 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.
  • Excellent technical writing skills and knowledge of submission/dossier documents.
  • If we need additional support, we will be sure to reach out directly to one of our preferred providers.

Requirements

  • 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).
  • Ability to work in a fast-paced environment managing multiple projects.
  • Ability to interpret regulations, assess impact, and propose compliant solutions.
  • Effective team player with the ability to influence cross-functional groups.
  • Working knowledge of international regulations in the EU MDR and APAC regions.
  • Review labelling changes, translation requirements, and provide regulatory support for updates as required.

Compensation

  • $107,500 - $125,000 + Bonus
  • 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.
  • Other rewards may include annual bonuses, long-term incentives based on level, paid time off, and region-specific benefits.

Benefits

  • $107,500 - $125,000 + Bonus
  • 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.

Company info

  • Hydrafacial is a global category-creating company focused on bringing innovative products to market and delivering beauty health experiences by reinventing our consumer's relationship with their skin, their bodies and their self-confidence.
  • Every person here is a key player in our success. We are firm believers in making the little things count each day so the big things will follow. If this sounds like you, come check us out! This is the perfect opportunity to work with some of the best leaders in the industry while you gain the global and strategic experience to add to your professional toolbox.
  • Job Description:
  • 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.
  • We are firm believers in making the little things count each day so the big things will follow.
  • This is the perfect opportunity to work with some of the best leaders in the industry while you gain the global and strategic experience to add to your professional toolbox.
  • 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.

Equal opportunity

  • Hydrafacial is proud to be an equal opportunity employer.
  • equal opportunity employer.
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