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 AD&D
- 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 & 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 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 & 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.
- Conducts regulatory reviews (license checks) for SS&DRs, CMDR licenses, RMLs, MDD, export control, and others as applicable.
- Author, review and submit License applications and Regulatory product registrations.
- Liaison and communicates with regulatory agencies and customers regarding licensing inquiries, product registrations, and import & export compliance to regulations.
- Assists in maintaining and updating DOT Special Form Certificates and Sealed Source Registrations.
- Supports additional regulatory systems and compliance as required.
- Maintains/supports EZIP’s Quality System documentation, including procedures, forms, drawings, transmittals, quality & company records, external standards
- Approves design files and design control drawings and ECO (Engineering Change Orders).
- Maintains technical files for CE Marking/medical devices and other products.
- Creates and edits procedures/forms.
- Manages electronic Document Management System.
- Supports records management.
- Maintains customer contact program.
- Evaluates customer complaints with input from Sales, Production and Engineering departments; maintains the Customer Contact database.
- Issues reports and/or memos on the status of complaints, as needed.
- Responsible for organizing and maintaining customer contact files.
- Communicates with customers and company managers the results of corrective action evaluations, conformance to product specifications, and preventive actions taken.
- Maintains CAPA system including issuance, follow-up, and closure of CAPAs.
- Review of any incident data and carry out necessary root cause analysis
- Reviewing marketing, legal and technical documentation to assess compliance
- Provides CAPA status to DQO, Operations, Sales, Production, and Managers of sister companies (EZC, EZN, and EZA, etc.).
- Follows-up corrective actions with suppliers, customers, and department managers through formal communications including on-site meetings, written letters, and email.
- Lead auditor for internal audits
- Conducts internal audits, including completion of audit reports.
- Issues Corrective Action / Preventive Action Requests (CAPARs) as necessary.
- Informs the DQO of audit results.
- Functions as lead auditor for supplier audits, as required.
- Performs audit of suppliers and completes audit reports.
- Performs receipt of customer returns and logs into appropriate logbooks and inventory control programs.
- Maintains returns database.
- Conducts capsule testing in compliance with ISO 2919 and DOT Special Form.
- Prepares test report documentation.
- Communicates results of testing compliance with managers, customers and regulatory agencies.
- Conducts Type A package testing in compliance with DOT regulations.
- Prepares test report documentation.
- Communicates results of testing compliance and provides DOT test reports to customers. a. Conducts Final QC on all EZIP product lines. (Back-up)
- Performs final QC on all orders except those specified by the Quality Systems Manager (Burbank facility) or Radioassay Manager (Valencia facility). (Back-up)
- Responsible for issuing, processing, closing, and filing of NCRs (Nonconformance reports).
- Supports the filing and record keeping of all QC documentation.
- Conducts Back-up Lead Quality Control duties as defined by the DQO.
- Performs inspection for accuracy and legibility on engravings, labels, boxes, or forms generated in-house or by outside vendors, as appropriate.
- Aids in conducting dimensional QC on components manufactured in-house or by outside vendors, as appropriate.
- Perform other duties as required by management.
Requirements:
- Minimum education (or substitute experience) required: Bachelor’s degree in a scientific field.
- Minimum experience required: 4+ years Regulatory Affairs or related discipline in medical devices or pharmaceuticals (R&D, Quality, etc.).
- Abilities and skills required:
- Certified Lead Auditor
- Must be able to travel and work in Valencia and occasionally in Burbank.
- Demonstrated experience authoring / reviewing / supporting a variety of regulatory submissions for US, Canada, Japan, Brazil, Australia, and EU.
- Knowledge and experience with FDA medical devices and/or pharmaceutical (drugs) regulations. Liaison with regulatory agencies. Performs internal audits.
- Experience in documentation and records administration.
- Experienced in QA systems: FDA, ISO 9001/13485, MDR/MDD, MDSAP (GMP)
- Proven technical and analytical skills through academia and/or work experience.
- Detail oriented, organized, excellent communication, verbal, and writing skills.
- Ability to lead and conduct internal, supplier, and customer audits.
- Self-starter, strong communicator, works independently, project management, manages to timelines.
- Basic submission and presentation related computer skills, including experience with software applications Microsoft Office, Teams, SharePoint, Adobe Acrobat, and ERP/MRP software
- Able to lift up to 25 lbs.
We are an equal opportunity employer. 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.
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