1+ months

Regulatory Specialist

Eckert & Ziegler Isotope Products, Inc.
Valencia, CA 91355
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  • Job Code
    134108064

Regulatory Specialist Valencia/Burbank, CA

Company Benefits

  • 100% employer paid medical and dental coverage
  • 401(k) matching contribution
  • Generous PTO and paid holidays
  • Short-term and long-term disability
  • Life and AD&D
  • Health Care and Dependent Care Flex Spending
  • Tuition reimbursement
  • Profit-sharing program

Company Overview

Contributing to Saving Lives

The Eckert & 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 & 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 & Ziegler Isotope Products seeks a Regulatory Specialist to work in both our Valencia and Burbank locations. This position assists the Regulatory Affairs Manager / Director of Quality Operations in maintaining an effective Quality Operations and Regulatory Program, which consistently delivers high quality EZIP products on time. Handles regulatory and technical submissions, CAPAs, customer complaints, and conducts regulatory reviews. Participates in audits to verify that appropriate, current procedures and applicable regulations are followed, and keeps the Regulatory Affairs Manager / Director of Quality Operations fully informed on status of QA, QC, DC, and RA activities.

Duties:

  • Assist in maintaining the Quality Management System and Regulatory Affairs Program.
  • Maintain FDA, NRC and CA-RHB product registrations and licensing.
  • Author, review and submit License applications and Regulatory product registrations.
  • Liaise and communicate with regulatory agencies and customers regarding licensing inquiries, product registrations, import & export compliance regulations.
  • Maintain/support EZIPs Quality System documentation.
  • Maintain technical files for CE Marking/medical devices and other products.
  • Create and edit procedures/forms.
  • Support Customer Contact Program.
  • Evaluate customer complaints and communicate the results of corrective action evaluations, conformance to product specifications, and preventive actions taken.
  • Maintain CAPA system including issuance, follow-up, and closure of CAPAs.
  • Lead auditor for internal audits.
  • Conduct internal audits, including completion of audit reports.
  • Function as lead auditor for external audits including completion of audit reports.
  • Back-up for receiving customer returns, capsule testing, package testing, final QC, and component QC.
  • Perform other duties as required by management.

Requirements:

  • Bachelors degree in scientific field.
  • Minimum 5 years experience in Quality Assurance and Regulatory Affairs.
  • Experience in a medical device environment.
  • Experience in pharmaceutical regulatory industry and requirements strongly desired.
  • Experience with QA systems: FDA, ISO 13485, MDR/MDD, MDSAP.
  • Knowledge of FDA medical devices and pharmaceutical (drugs) registrations (510k, DMF, NDA, ANDA)
  • Self-starter and strong communicator.
  • Ability to work independently and in a team environment.
  • Project management experience and ability to manage timelines.
  • Detail oriented, organized, excellent written and verbal skills.
  • Excellent planning, organization, and flexibility to adjust to changing environment.
  • Proficient in Microsoft Word, Excel, ERP/MPR software, Access, and Smart Draw or equivalent flowcharting program. Strong IT background.
  • Must be able to travel and work in Burbank and Valencia.

Qualifications:

  • Lead Auditor Certificate.
  • Knowledge of Medical Devices and Pharmaceutical Regulations
  • Qualified on all QA procedures and License Compliance program.
  • Able to perform and lead supplier and internal audits
  • DOT 49 CFR/IATA and radiation worker qualification.
  • Document control procedures and record keeping.

Equal Opportunity Employer Veterans Disabled. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against, on the basis of disability.

To apply please click on the link below or copy and paste into your browser.

https://workforcenow.adp.com/mascsr/default/mdf/recruitment/recruitment.html?cid=9c980abd-e7ad-4b5f-9517-39477f587807&ccId=19000101_000001&jobId=409214&source=CC2&lang=en_US






PI134108064

Posted: 2021-04-14 Expires: 2021-05-16

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Regulatory Specialist

Eckert & Ziegler Isotope Products, Inc.
Valencia, CA 91355

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