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Regulatory Affairs Sr. Specialist

Regulatory Affairs Sr. Specialist

SprintRayHuntington Beach, CA, US
8 days ago
Job type
  • Full-time
Job description

Job Description

Job Description

Regulatory Affairs Sr. Specialist

Location : Hybrid - Huntington Beach (some travel to Los Angeles)

Compensation : $110,000 – $120,000 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 to improve patient outcomes.

We are seeking a highly motivated Regulatory Affairs Senior 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 regulatory submissions and documentation for SprintRay medical device products.
  • Provide regulatory guidance and expertise to product development, quality, and other cross-functional teams.
  • Monitor and interpret changes in regulatory requirements and standards, assessing impact on current products and processes.
  • Support internal audits and external inspections to ensure regulatory compliance.
  • Collaborate with global teams to align product development and quality practices with regulatory expectations.
  • Performs other related duties and projects as business needs require at direction of management.
  • Required Qualifications

  • Bachelor’s degree in a scientific discipline or related field (Master’s or Ph.D. preferred)
  • 5+ years of experience in all aspects of Global Regulatory Affairs within the medical device industry
  • Comprehensive knowledge of US 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 at all levels
  • Strong prioritization and time management skills
  • In-depth understanding of related State and Federal regulations and procedures
  • Commitment to a high standard of quality in all work outputs
  • Solid knowledge of FDA 510(k) requirements and ISO 13485 standards
  • Expertise in Regulatory Affairs practices including Good Manufacturing Practices (GMP), training programs, SOP development, and audits / inspections
  • Demonstrated reliability, dependability, and flexibility in work habits
  • Exceptional attention to detail and accuracy
  • Proven ability to prioritize and organize project tasks and goals effectively
  • High level of integrity, trustworthiness, and confidentiality
  • Ability to research and evaluate new and emerging technologies and practices
  • 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?

    Equal Opportunity Employer

    SprintRay is proud to be an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.

    To All Recruitment Agencies :

    Without a written agreement signed by an officer of SprintRay : a) SprintRay does not accept resumes from recruiting agencies, headhunters, or any other party expecting payment in the event SprintRay speaks with or hires a candidate from such submitted resume; b) SprintRay is not responsible for any fees related to unsolicited resumes or related Terms of Service, and c) Unsolicited resumes received will be considered the property of SprintRay and will be processed accordingly.

    Accessibility

    If you need a reasonable accommodation during the application or interview process, please contact us at people.services@sprintray.com.

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    Regulatory Specialist • Huntington Beach, CA, US

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