Regulatory Affairs and Quality Assurance SpecialistLocation: Huntington Beach, CA
Compensation: $90,000 - $120,000 annually (depending on experience)
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.Key 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
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
- 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
Employment TypeFulltime, Onsite
Department Regulatory Affairs Locations Huntington Beach Yearly salary $90,000 - $120,000
