Regulatory Affairs Specialist

Location: Hybrid - Huntington Beach (some travel to Los Angeles)
Compensation: $90,000 – $110,000 annually (depending on experience)

About the Role

At SprintRay, we are in a super-charged growth mode, constantly innovating while maintaining the highest quality standards for our products and processes. Our mission is to deliver safe, reliable, and innovative medical devices that improve patient outcomes.

We are seeking a highly motivated Regulatory Affairs Specialist to support our medical device portfolio. This role is critical in ensuring compliance with global regulatory requirements and providing guidance on applicable standards. The ideal candidate will be proactive, detail-oriented, and experienced in navigating the regulatory landscape for medical devices.

Key Responsibilities

• Provide regulatory support to ensure compliance with:
  • EU MDR
  • FDA QSR
  • ISO 13485 / MDSAP
• Prepare, review, and maintain Post-Market Surveillance (PMS) documentation and Usability Study Reports
• Prepare, review, and maintain Clinical Evaluation Reports (CERs) and Periodic Safety Update Reports (PSURs)
• Support clinical and post-market activities, including PMCF plans, PMCF reports, vigilance reporting, and trend analysis
• Prepare, review, and maintain GSPRs and complete Technical File/Technical Documentation submissions for the EU and MDSAP countries
• Prepare and support global regulatory submissions, including FDA 510(k), EU Technical Documentation, and registrations in Canada, UK, LATAM, and APAC
• Review and approve product labeling, including IFUs, packaging, and marketing materials
• Ensure UDI compliance for U.S., EU, and other global jurisdictions
• Manage product lifecycle regulatory activities, including change assessments, regulatory impact reviews, and labeling updates
• Coordinate with Notified Bodies regarding audits, technical documentation submissions, and responses to questions
• Prepare responses to regulatory agency questions, deficiency letters, and nonconformities
• Maintain regulatory databases and tracking systems to ensure timely submissions and renewals
• Conduct regulatory intelligence activities to monitor new or changing regulations and communicate impacts to internal stakeholders
• Provide regulatory input during design reviews, engineering changes, and risk management activities

Required Qualifications

• Bachelor’s degree in a scientific discipline or related field (Master’s or Ph.D. preferred)
• 5+ years of experience in Global Regulatory Affairs and Quality Assurance within the medical device industry
• Comprehensive knowledge of U.S. and international medical device regulations and standards (e.g., Canada, EU, Japan, LATAM)
• Experience in risk management per ISO 14971:2019
• Ability to effectively engage with Notified Bodies and regulatory agency representatives
• Thorough understanding of relevant State and Federal regulations
• Solid knowledge of FDA 510(k), and EU MDR requirements as well as ISO 13485 standards
• Ability to research and evaluate new and emerging technologies and regulatory practices
• Understanding of Design Controls (21 CFR 820.30) and ISO 13485 documentation requirements
• Familiarity with document control, records management, and QMS documentation practices
• Knowledge of complaint handling, vigilance reporting, and trend analysis
• Experience reviewing ECOs for quality and regulatory impact
• Experience supporting QMS implementation or continuous improvement initiatives
• Demonstrated reliability, dependability, and flexibility
• Exceptional attention to detail and accuracy
• High level of integrity, trustworthiness, and ability to maintain confidentiality
• Strong prioritization, organization, and time-management skills
• Strong technical writing and documentation skills
  

Employment Type

Full-time

About SprintRay

SprintRay is rewriting the rules of dentistry with technology that’s smart, fast, and designed to make life easier for dental professionals. Since 2014, we’ve been on a mission to deliver the most advanced 3D printing solutions in the industry—combining hardware, software, and materials into one seamless ecosystem.

But what really makes SprintRay different is our people. We’re a bold, global team of innovators, problem-solvers, and doers who thrive on pushing boundaries and challenging the status quo. Every product we create is driven by a simple goal: help dentists spend less time on repetitive tasks and more time changing patients’ lives.

Our culture is entrepreneurial, collaborative, and fueled by curiosity. We celebrate diverse perspectives and believe the best ideas can come from anywhere. Whether we’re building next-generation AI tools, designing new materials, or supporting our customers on the front lines, we’re united by the same passion—transforming digital dentistry and having fun while we do it.

At SprintRay, the future of dentistry is being printed today. Want to be part of it?