Regulatory Specialist

Jobot Consulting; Santa Clarita (CA); On-site; USD 80,000 - 90,000; Full time

Job summary

A leading medical device company in Santa Clarita is seeking a Regulatory Affairs and Quality Assurance Coordinator. This entry-level role involves ensuring compliance with regulatory standards and maintaining the quality management system. Ideal candidates will be detail-oriented and have a relevant degree, contributing to a growing organization with a strong culture and work-life balance.

Benefits

Great work-life balance

Inclusive work environment

Qualifications

• Seeking candidates with a degree in a relevant field.
• Experience in regulatory compliance and quality management systems is preferred.
• Detail-oriented with strong communication skills.

Responsibilities

• Support compliance with regulatory requirements and maintain quality management systems.
• Conduct regulatory reviews and manage documentation for product registrations.
• Lead internal audits and assist in maintaining ISO compliance.

Skills

Detail-oriented

Regulatory compliance

Quality management

Education

Degree in a relevant field

Job description

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Base pay range

$80,000.00/yr - $90,000.00/yr

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Job details

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 "Easy Apply" button 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

Interested in hearing more? Easy Apply now by clicking the "Easy Apply" 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.

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Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Contract

Job function

• Job function

  Legal

• Industries

  Biotechnology Research, Research Services, and Nanotechnology Research

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