Regulatory Affairs Specialist

Join to apply for the Regulatory Affairs Specialist role at Eckert & Ziegler Isotope Products

21 hours ago Be among the first 25 applicants

Join to apply for the Regulatory Affairs Specialist role at 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

  Medical Equipment Manufacturing

Referrals increase your chances of interviewing at Eckert & Ziegler Isotope Products by 2x

Get notified about new Regulatory Affairs Specialist jobs in Santa Clarita, CA .

Santa Clarita, CA $38.00-$48.00 3 days ago

Santa Clarita, CA $38.46-$48.08 2 days ago

Santa Clarita, CA $35.00-$42.00 4 days ago

Santa Clarita, CA $35.00-$42.00 4 days ago

Santa Clarita, CA $86,600.00-$164,500.00 2 weeks ago

Santa Clarita, CA $95,000.00-$135,000.00 3 days ago

Santa Clarita, CA $100,000.00-$140,000.00 21 hours ago

Burbank, CA $95,000.00-$135,000.00 3 days ago

Santa Clarita, CA $100.00-$140.00 3 weeks ago

Santa Clarita, CA $100,000.00-$140,000.00 1 hour ago

Thousand Oaks, CA $36.60-$38.90 2 weeks ago

Thousand Oaks, CA $30.00-$35.00 15 hours ago

Non-Default Quality Assurance and Quality Control Specialist I

Moorpark, CA $40,000.00-$60,000.00 6 days ago

Specialist, Quality Engineer - Metrology

Los Angeles, CA $82,500.00-$153,000.00 2 weeks ago

Sr Specialist, Process Quality Engineer 1

Specialist, Quality Assurance Planning Engineer - Special Process 1

NDT Level III RT/DR, Quality Engineering Specialist

Los Angeles, CA $114,000.00-$212,000.00 2 weeks ago

Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.