Regulatory Affairs & Quality Associate

SprintRay Inc.; Huntington Beach (CA); Ibrido; USD 80.000 - 95.000; Tempo pieno

Descrizione del lavoro

SprintRay Inc. in Huntington Beach, CA is hiring a Regulatory Affairs & Quality Associate to ensure global regulatory and quality compliance for our medical device portfolio.

The role demands a proactive, detail-oriented professional with experience navigating regulatory landscapes, contributing to PMS, CERs, PMCF, PSURs, and audits, while working closely with Quality, R&D, Engineering, and Manufacturing teams.

Competenze

• Bachelor’s degree in engineering, Life Sciences, Regulatory Affairs, Biomedical Sciences, or a related technical/scientific field.
• 0-3 years of experience in Regulatory Affairs, Quality Assurance, or related function in medical devices preferred.
• Familiarity with ISO 13485 and FDA QSR; experience with medical device regs preferred.
• Basic understanding of EU MDR and post-market surveillance requirements preferred.
• Strong attention to detail, accuracy, and organizational skills.
• Ability to manage multiple priorities and deadlines in a fast-paced environment.
• Strong written and verbal communication skills.
• Strong technical writing and documentation skills.
• Ability to review technical and regulatory documentation for accuracy and compliance.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
• Ability to work independently and with cross-functional teams.

Mansioni

• Prepare, review, and maintain Post-Market Surveillance (PMS) Reports per regulatory requirements.
• Prepare and maintain Usability Engineering / Human Factors Reports and related documentation.
• Prepare, review, and maintain Clinical Evaluation Reports (CERs).
• Prepare Post-Market Clinical Follow-Up (PMCF) Reports and supporting documentation.
• Prepare Periodic Safety Update Reports (PSURs), as applicable.
• Support medical device complaint handling, including review and documentation of complaints and investigations with cross-functional teams.
• Coordinate complaint investigations with Quality, Engineering, Manufacturing, and other departments.
• Prepare and maintain complaint investigation reports and capture root cause and CAPAs.
• Support complaint trending and regulatory reporting as needed.
• Review controlled documents for regulatory compliance across Design Control, Process Validation, Risk, Manufacturing, and product docs.
• Support document control activities including numbering, routing, DCOs, and archival.
• Maintain accurate controlled document records in the QMS and ensure traceability.
• Review and approve product labeling, IFUs, packaging, and SDSs for regulatory compliance.
• Support regulatory submissions and EU registrations; assist audits as needed.
• Collaborate with cross-functional teams to meet regulatory and QMS requirements.

Conoscenze

Regulatory affairs knowledge

Attention to detail

Analytical thinking

Written & verbal communication

Cross-functional collaboration

MS Office proficiency

Formazione

Bachelor’s degree in engineering, Life Sciences, Regulatory Affairs, Biomedical Sciences, or related field

Strumenti

Microsoft Office

Descrizione del lavoro

Regulatory Affairs & Quality Associate

Location: Huntington Beach, CA
Compensation: $80,000 - $95,000k (Depending on experience)

About the Role

At SprintRay, we are in a super-charged growth mode, constantly innovating while maintaining thehighest 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 candidate to support our medical device portfolio. This role is critical in ensuring compliance with global regulatory and quality 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. This role requires strong analytical skills, attention to detail, and a collaborative approach to regulatory compliance.

Key Responsibilities

• Prepare, review, and maintain Post-Market Surveillance (PMS) Reports in accordance with applicable regulatory requirements.

• Prepare and maintain Usability Engineering / Human Factors Reports and related documentation.

• Prepare, review, and maintain Clinical Evaluation Reports (CERs).

• Prepare Post-Market Clinical Follow-Up (PMCF) Reports and supporting documentation.

• Prepare Periodic Safety Update Reports (PSURs), as applicable.

• Support the medical device complaint handling process, including:

  • Review and documentation of customer complaints.

  • Evaluation of complaints for reportability and regulatory impact.

  • Coordination of complaint investigations with Quality, Engineering, Manufacturing, and other relevant departments.

  • Preparation and maintenance of complaint investigation reports.

  • Identification and documentation of root cause, investigation findings, and corrective actions, as applicable.

  • Support complaint trending and trend reporting to identify potential product quality, safety, or performance signals.

  • Support vigilance reporting and regulatory reporting when required.

• Review controlled documents from cross-functional departments for regulatory compliance, accuracy, completeness, and consistency, including:

  • Design Control documentation

  • Process Validation documentation

  • Risk management documentation

  • Manufacturing and quality documentation

  • Regulatory and product documentation

• Support document control activities, including:

  • Assignment and maintenance of controlled document numbers and naming conventions.

  • Document routing and approval workflows.

  • Document Change Orders (DCOs) and document change control.

  • Revision tracking and implementation.

  • Maintenance and archival of obsolete documents.

  • Ensuring appropriate approvals and effective dates are documented.

• Maintain accurate and up-to-date controlled document records in accordance with the company's Quality Management System (QMS).

• Review and approve product labeling, including labels, Instructions for Use (IFUs), packaging, and applicable product information, for regulatory and quality compliance.

• Review and approve Safety Data Sheets (SDSs) and ensure consistency with applicable regulatory and product requirements.

• Support product change assessments, including evaluation of regulatory and quality impacts associated with product, process, material, labeling, manufacturing, and supplier changes.

• Support preparation and maintenance of EUDAMED registrations and related EU regulatory information.

• Support EU REACH compliance and product registrations, including collection, review, and maintenance of required product and material information.

• Maintain regulatory and product registration records and support regulatory submission and registration activities as needed.

• Assist with preparation for and follow-up on internal, external, regulatory, and Notified Body audits.

• Support responses to audit findings, regulatory inquiries, and documentation requests.

• Collaborate with Quality, Regulatory, R&D, Engineering, Manufacturing, Clinical, and other cross-functional teams to ensure regulatory and QMS requirements are met.

• Monitor applicable regulatory requirements and support implementation of new or revised regulations, standards, and guidance.

• Maintain confidentiality and ensure the integrity, accuracy, and traceability of regulatory and quality records.

Required Qualifications

• Bachelor’s degree in engineering, Life Sciences, Regulatory Affairs, Biomedical Sciences, or a related technical/scientific field.

• 0-3 years of experience in Regulatory Affairs, Quality Assurance, or a related function within the medical device industry is preferred.

• Familiarity with ISO 13485 and FDA Quality System requirements; experience with medical device regulations is preferred.

• Basic understanding of EU MDR and post-market surveillance requirements is preferred.

• Strong attention to detail, accuracy, and organizational skills.

• Ability to manage multiple priorities and deadlines in a fast-paced environment.

• Strong written and verbal communication skills.

• Strong technical writing and documentation skills.

• Ability to review technical and regulatory documentation for accuracy, completeness, consistency, and compliance.

• Proficiency in Microsoft Office Suite, particularly Word, Excel, and PowerPoint.

• Ability to work independently while also collaborating effectively within a cross-functional team.

• Demonstrated ability to maintain confidentiality, document integrity, and accurate records.

• Strong analytical and problem-solving skills, with the ability to identify discrepancies and follow issues through resolution.

• Willingness and ability to learn and apply new regulatory requirements, standards, and internal procedures.

Employment Type

Full-time

About SprintRay

SprintRay is rewriting the rules of dentistry with technology that is 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.

Accessibility

If you need a reasonable accommodation during the application or interview process, please contact us at [e-mail].