REGULATORY AFFAIR SPECIALIST

Regulatory Affairs SpecialistBroadata Communications, Inc. (BCI) – Torrance, CA On-site Company OverviewBroadata Communications, Inc. (BCI) is a privately held California-based corporation. BCI is a leading and innovative company specializing in the development of market-driven products for the transmission of digital multimedia (video, audio, and data) over fiber. Our clients are world leaders in their industries, spanning entertainment, broadcast, medical, professional audio/video, house of worship, education, government, military, and transportation sectors. We are ISO 13485 and ISO 9001 certified, with a strong commitment to quality, innovation, and continuous improvement.Job SummaryBroadata Communications, Inc. is seeking a Regulatory Affairs Specialist to support the company’s medical device compliance activities, regulatory documentation, and quality system requirements. This role will support Class I and Class II medical device programs, including technical documentation, design history files, change control, risk management, supplier documentation, labeling review, customer regulatory requests, and audit readiness.The ideal candidate has hands-on experience working in an FDA-regulated and ISO 13485 environment, with a strong understanding of Class I medical device requirements. Experience with Class II medical devices, 510(k) support, IEC 60601-1, EU MDR technical documentation, or customer-driven regulatory submissions is highly preferred.This is an excellent opportunity for a detail-driven professional who thrives in a high-tech manufacturing environment and values teamwork, accountability, and continuous improvement. This critical, hands-on role is based in Torrance, CA. We offer a fast-paced, high impact and stimulating work environment with opportunities for professional growth and development within BCI. Veterans welcome!This is a hands-on position. This is NOT a remote or hybrid position.Key ResponsibilitiesSupport regulatory compliance activities for medical device products manufactured or supported by BroadataMaintain and update regulatory documentation for Class I medical devices; support Class II documentation where applicableAssist with Design History Files, Device Master Records, Technical Files, and regulatory evidence packagesSupport FDA 21 CFR Part 820 / QMSR transition activities, ISO 13485 compliance, and customer-specific regulatory requirementsReview and approve product labeling, IFUs, specifications, drawings, procedures, and quality records for regulatory complianceSupport risk management files in accordance with ISO 14971, including hazard analysis, risk controls, and traceabilityAssist with change control assessments to determine regulatory impactSupport internal audits, external audits, customer audits, and certification body auditsWork cross-functionally with Quality, Engineering, Manufacturing, Supply Chain, and Program Management to ensure regulatory requirements are understood and implementedSupport EU MDR, FDA, and international regulatory documentation requests as neededAssist in preparing regulatory responses, customer questionnaires, compliance letters, and technical documentation packagesMaintain awareness of applicable standards, regulations, and guidance documentsSupport supplier regulatory documentation, including declarations, certificates, compliance forms, and supplier change notificationsHelp ensure product documentation is complete, accurate, controlled, and audit-readyJob responsibilities within our organization are dynamic. This may not be a complete list of duties. Other responsibilities and duties may be assigned by your supervisor or upper management.Education & ExperienceBachelor’s degree in Engineering, Life Sciences, Regulatory Affairs, Quality, or related technical disciplineMinimum 8-10 years of experience in Regulatory Affairs, Quality Assurance, or Compliance within a medical device environmentHands-on experience with Class I medical devices requiredWorking knowledge of FDA 21 CFR Part 820, ISO 13485, and medical device documentation requirementsExperience supporting technical documentation, DHF/DMR files, change control, labeling review, and audit preparationStrong attention to detail and ability to manage documentation in a controlled QMS environmentAbility to work cross-functionally with Engineering, Quality, Operations, and external customersStrong written and verbal communication skillsAbility to organize regulatory information clearly and respond to customer or auditor requests in a professional mannerExperience with Class II medical devices strongly preferredExperience supporting 510(k), FDA submissions, EU MDR technical files, or international registrations preferredFamiliarity with IEC 60601-1, IEC 62304, IEC 62366, ISO 14971, and electrical medical device requirements preferredExperience in a contract manufacturing or complex electromechanical manufacturing environment preferredExperience with customer audits from large medical device OEMs preferredExperience with QT9, NetSuite, Master Control, Greenlight Guru, Arena, or similar eQMS/ERP systems preferredRAC certification or regulatory affairs coursework preferred but not requiredSkills & AbilitiesExcellent organizational skills and strong attention to detailProactive and capable of managing multiple priorities while adapting to changing business needsEffective communication and collaboration skills across departmentsComfortable working in a fast-paced, cross-functional team environment, working extended hours (as needed)Strong self-motivation and attitude for personal career growth, willingness to self-learn, and work in new technology domainsProficient in Microsoft Excel and working knowledge of Microsoft Office SuitePhysical Job RequirementsThe employee in the position will be required to occasionally move throughout the facilities, including climbing stairs, when necessary. Occasional bending and reaching in an office environment, including opening and closing file cabinets drawers with light grasping. Type on a standard keyboard (laptop or desktop). Use standard computer display screens. Use standard push-button phones and must speak clearly and be understood by others. Sit or stand in a standard upright position for a minimum of one hour, but up to 12 hours a day. Be able to lift and carry weight unassisted not exceeding 50 lbs.Compensation And BenefitsSalary Range: $120k - $150k (based on experience and qualifications)Medical, vision and dental insurance401(k) with company match (100% of the first 4% in eligible compensation)Flexible Spending Account 2 weeks paid vacation1 Week sick pay10 company holidaysGroup life insurancePowered by JazzHRH0u2irg2cX