Regulatory Affairs and Quality Assurance Specialist

SprintRay•Huntington Beach, CA

21h•Onsite

About The Position

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 and Quality Assurance Specialist to support our medical device portfolio. This role is critical in ensuring compliance with global regulatory requirements and strengthening our Quality Management System. The ideal candidate will be proactive, detail-oriented, and experienced in navigating the regulatory and quality landscape for medical devices.

Requirements

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
Strong prioritization, organization, and time-management skills
Thorough understanding of relevant State and Federal regulations
Solid knowledge of EU MDR requirements as well as ISO 13485 standards
Expertise in RA/QA practices including GMP, SOP development, training programs, and audit readiness
Experience supporting NCRs, complaint investigations, and quality event documentation
Understanding of Design Controls (21 CFR 820.30) and ISO 13485 documentation requirements
Experience conducting or supporting internal, supplier, and external audits
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
Ability to research and evaluate new and emerging technologies and regulatory practices
Strong technical writing and documentation skills

Responsibilities

Provide regulatory support to ensure compliance with: EU MDR, FDA QSR, ISO 13485 / MDSAP
Review and approve product labeling, including IFUs, packaging, and marketing materials
Ensure UDI compliance for U.S., EU, and other global jurisdictions
Prepare, review, and maintain GSPRs and complete Technical Documentation submissions for the EU, MDSAP countries and other markets
Prepare and support global regulatory submissions, including registrations in US, EU, Canada, UK, LATAM, and APAC
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
Support complaint handling, including triage, documentation, and cross-functional coordination
Participate in internal audits, supplier audits, and preparation for external audits (FDA, Notified Body, MDSAP)
Support Design Controls, including reviewing risk files, DHF documentation, and change controls
Review ECOs/ECRs for quality and regulatory impact
Assist in maintaining and improving the Quality Management System (QMS) in alignment with ISO 13485, EU MDR, and 21 CFR 820
Support document control, records management, and quality system procedures
Assist with MDR/Vigilance evaluation and reporting, including trend analysis
Support and participate in training programs related to RA/QA requirements
Perform other related duties and projects as assigned by management