Job Description
CONTRACT - Regulatory Specialist needed in Santa Clarita, CA - ONSITE This Jobot Consulting Job is hosted by: Victoria Casal
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and sending us your resume.
Salary: $80,000 - $90,000 per year
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 Coordinator 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
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Job Tags
Contract work, Part time, Immediate start,