Regulatory Specialist
Location: Santa Clarita
Posted on: June 23, 2025
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Job Description:
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.
Keywords: , East Los Angeles , Regulatory Specialist, Science, Research & Development , Santa Clarita, California
