Regulatory Specialist

CONTRACT - Regulatory Specialist needed in Santa Clarita, CA - ONSITE This Jobot Consulting Job is hosted by: Victoria Casal Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $35 - $42 per hour A bit about us: THIS IS NOT A REMOTE ROLE. Growing Medical Device Company! Industry leading Why join us? Great growing organization to be a part of with a great work life balance/culture. Job Details THIS IS NOT A REMOTE ROLE. JOB DESCRIPTION: JOB TITLE: Regulatory Affairs and Quality Assurance Coordinator POSITION SUMMARY: We are seeking a detail-oriented Regulatory Affairs and Quality Assurance Specialist to support our company's compliance with regulatory requirements and maintain our quality management system. This role will work under the guidance of the Regulatory Affairs Manager and DQO to ensure compliance with company quality operations and regulatory affairs program. KEY RESPONSIBILITIES: Regulatory Affairs and Quality Management System Support in maintaining an ISO 9001, CMDR, FDA (21 CFR 820), FDB, NRC 10 CFR 50 Appendix B, DOT (49 CFR) / IAEA, BIS (Bureau of Industry & Security), Medical Device Directive (93/42/EEC), ISO 17025, ISO 13485, MDR/MDD, MDSAP compliant Quality System Maintain NRC and CA-RHB (Radiological Health Branch) product registrations and licensing Conduct regulatory reviews and author, review and submit License applications and Regulatory product registrations Liaise and communicate with regulatory agencies and customers regarding licensing inquiries, product registrations, and import & export compliance to regulations Assist in maintaining and updating DOT Special Form Certificates and Sealed Source Registrations Support additional regulatory systems and compliance as required Document Control Administration Maintain/support EZIP's Quality System documentation, including procedures, forms, drawings, transmittals, quality & company records, external standards Approve design files and design control drawings and ECO (Engineering Change Orders) Maintain technical files for CE Marking/medical devices and other products Create and edit procedures/forms Manage electronic Document Management System Support records management Customer Complaints and Returns Maintain customer contact program Evaluate customer complaints with input from Sales, Production, and Engineering departments; maintain the Customer Contact database Issue reports and/or memos on the status of complaints, as needed Organize and maintain customer contact files Communicate with customers and company managers the results of corrective action evaluations, conformance to product specifications, and preventive actions taken CAPA Maintain CAPA system including issuance, follow-up, and closure of CAPAs Review any incident data and carry out necessary root cause analysis Review marketing, legal, and technical documentation to assess compliance Provide CAPA status to DQO, Operations, Sales, Production, and Managers of sister companies (EZC, EZN, and EZA, etc.) Follow up corrective actions with suppliers, customers, and department managers through formal communications including on-site meetings, written letters, and email Internal Audits Lead auditor for internal audits Conduct internal audits, including completion of audit reports Issue Corrective Action / Preventive Action Requests (CAPARs) as necessary Inform the DQO of audit results External Audits of Suppliers Function as the lead auditor for supplier audits, as required Perform audit of suppliers and complete audit reports Receiving of Customer Returns (Back-up) Perform receipt of customer returns and log into appropriate log books and inventory control programs Maintain returns database Capsule Testing and Product Validation (Back-up) Conduct capsule testing in compliance with ISO 2919 and DOT Special Form Prepare test report documentation Communicate results of testing compliance with managers, customers and regulatory agencies Package Testing (Back-up) Conduct Type A package testing in compliance with DOT regulations Prepare test report documentation Communicate results of testing compliance and provide DOT test reports to customers Final Quality Control (Back-up) Conduct final QC on all EZIP product Interested in hearing more? Easy Apply now by clicking the "Apply Now" button. Jobot is an Equal Opportunity Employer. We provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. Sometimes Jobot is required to perform background checks with your authorization. Jobot will consider qualified candidates with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance.

Location: Santa Clarita, CA, US

Posted Date: 6/6/2025