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Eckert & Ziegler Isotope Products, Inc.

Regulatory Affairs Specialist

Eckert & Ziegler Isotope Products, Inc., Santa Clarita, California, United States, 91382

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Regulatory Affairs Specialist

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Eckert & Ziegler Isotope Products Get AI-powered advice on this job and more exclusive features. Regulatory Affairs Specialist - Valencia, CA (Occasionally in Burbank)

Company Benefits

100% employer paid medical and dental

401(k) matching contribution

Generous PTO and paid holidays

Long-term disability

Life and ADandD

Health Care and Dependent Care Flex Spending

Tuition reimbursement

Profit-sharing program

Pay: $38.46 - $48.08

hourly (DOE)

Position is Onsite

Company Overview

Contributing to Saving Lives

The Eckert and Ziegler Group

is one of the world's largest providers of isotope technology for medical, scientific, and industrial use.

The core businesses of the Group are Diagnostic Nuclear Medicine Imaging, Cancer Therapy, and Industrial Radiometry

Business Segment Overview

Eckert and Ziegler Isotope Products

provides sealed and unsealed radiation sources and materials for

Medical Imaging sources; Industrial sources for measurement and analysis; Oil Well Logging sources and related products; Reference, Calibration and Environmental Monitoring sources and solutions; Bulk radioisotopes for pharmaceutical, therapeutic and industrial product manufacturing; Services for collection, recycling and disposal of sources and low-activity waste; Sources for industrial Non-Destructive Testing; High-Activity radiation sources for radiation processing and sterilization; Medical and Industrial irradiators for blood irradiation, sterilization or calibration.

The Job

Eckert and Ziegler Isotope Products seeks a **Regulatory Affairs Specialist** to join our team. The Regulatory Affairs Specialist assists the Director of Quality Operations (DQO) in maintaining an effective Quality Operations and Regulatory Program, which consistently delivers high quality company products on time. Handles regulatory submissions, CAPAs, customer complaints, conducts regulatory reviews and participates in audits to verify that appropriate current procedures and applicable regulations are followed, and keeps the DQO fully informed on status of QA, QC, DC, and RA activities.

Essential Duties

Operates under the guidance of the Regulatory Affairs Manager and DQO to assure compliance with the company Quality Operations and Regulatory Affairs program.

Communicates with the Regulatory Affairs Manager on QA/QC/RA/DC activities.

Assists 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 and Security), Medical Device Directive (93/42/EEC), ISO 17025, ISO 13485, MDR/MDD, MDSAP compliant Quality System. Seniority level

Seniority level

Entry level Employment type

Employment type

Full-time Job function

Job function

Legal Industries

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