Regulatory Affairs Specialist

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: $42.00 - $50.00 hourly (DOE)

Position is Onsite

The Job

Eckert & Ziegler Isotope Products seeks a Regulatory Affairs Specialist to join our team. The Regulatory Affairs Specialist assists their manager in maintaining an effective Quality Operations and Regulatory Program, which consistently delivers high-quality EZIP products on time. Manages international regulatory submissions, classification, and market-entry strategy serving as the main contact for regulators and distributors while tracking registrations and renewals. Participates in audits to verify that appropriate current procedures and applicable regulations are followed, and keeps the Director of Quality Operations and the Quality Assurance & Regulatory Manager fully informed on status of QA, QC, and RA activities.

ESSENTIAL DUTIES:

1. Operates under the guidance of the Director of Quality Operations / Quality Assurance & Regulatory Manager to ensure compliance with the company's Quality Operations and Regulatory Affairs program and communicates regularly on QA/QC/RA activities.
2. Assists in maintaining an ISO 9001, CMDR, FDA (21 CFR 820), FDB, CFR 50 Appendix B, DOT (49 CFR) / IAEA, BIS (Bureau of Industry & Security), Medical Device Directive (93/42/EEC / EU MDR (2017/745/EU), ISO 17025, ISO 13485 compliant Quality System.
3. Assists in maintaining NRC and CA-RHB product registrations and licensing, including DOT Special Form Certificates and Sealed Source Registrations.
4. Conducts regulatory reviews (license checks) and communicates with the NRC, state agencies, and customers on licensing, registration, and import/export compliance, while supporting additional regulatory systems as required.
5. Compiles, formats, and submits dossiers, technical files, and registration documents to foreign health and nuclear regulatory agencies and notified bodies.
6. Determines the correct international classification, jurisdiction, and approval route for products, and assesses evolving global regulations and standards to shape market-entry strategies.
7. Serves as the point of contact for regulatory agencies and in-country distributors, and tracks existing registrations, renewals, and expiration dates.
8. Drafts, submits, and tracks export license applications with agencies such as BIS and the NRC, and maintains compliance files for all licenses and export documentation.
9. Classifies products under the EAR (Commerce Control List ECCNs), determines NRC vs. BIS jurisdiction, and assigns accurate HTS and Schedule B codes for correct customs declarations.
10. Performs denied party and restricted-end-user screening before foreign distribution and prepares, submits, and tracks due diligence reports to the parent company for shipments to high-risk countries.
11. Maintains the Quality System documentation (procedures, forms, drawings, transmittals, records, and external standards) and technical files for CE Marking/medical devices and other products.
12. Approves design files, design control drawings, and ECOs, and edits documents as required for areas of responsibility.
13. Maintains the customer complaint and feedback system, manages and improves the complaints/returns process, and updates procedures as needed.
14. Evaluates complaints with input from Sales, Production, and Engineering; approves nonconformance reports and returns/complaints analyses; and maintains the Customer Contact database and files.
15. Issues status reports on complaints, and coordinates meetings to evaluate product defects and submit reports to the Director of Quality Operations.
16. Communicates corrective action results, conformance to product specifications, and preventive actions to customers and company managers.
17. Issues and maintains the CAPA system, including issuance, follow-up, and closure, and reports CAPA status to the Director of Quality Operations, Sales, Production, and managers of sister companies.
18. Follows up on corrective actions with suppliers, customers, and department managers through on-site meetings, letters, and email.
19. Performs lead and internal audits, completes audit reports, and issues CAPARs as necessary.
20. Informs the Director of Quality Operations / Quality Assurance & Regulatory Manager of audit results.
21. Performs supplier audits and surveys as required and completes the associated reports.
22. Performs other duties as required by management.

BACK-UP RESPONSIBILITES:

1. Receives customer returns, logs them into the appropriate logbooks and inventory control programs, and maintains the returns database.
2. Conducts capsule testing in compliance with ISO 2919 and DOT Special Form and prepares test report documentation.
3. Communicates testing results and compliance to managers, customers, and regulatory agencies.
4. Conducts Type A package testing in compliance with DOT regulations and prepares test report documentation.
5. Communicates results and provides DOT test reports to customers.
6. Conducts Final QC on all Company product lines, except orders designated by the Quality Systems Manager (Burbank) or Radioassay Manager (Valencia).
7. Issues, processes, closes, and files NCRs, and supports filing and record keeping of all QC documentation.
8. Conducts Back-up Lead Quality Control duties as defined by the Director of Quality Operations.
9. Inspects engravings, labels, boxes, and forms (in-house or vendor-produced) for accuracy and legibility, and aids in dimensional QC on components.
10. Conducts calibration activities and IMTE maintenance, as assigned.

Requirements:

• Minimum education (or substitute experience) required: Bachelor's degree in a scientific field.
• Minimum experience required: Minimum 4 years of regulatory affairs or related discipline (e.g. quality assurance, technical assessments, and document management). Experience in a medical device environment desired.
• Abilities and skills required:
  • Excellent communication, verbal, and writing skills.
  • Experience with ISO 9001, ISO 13485, MDSAP, MDR/MDD, and/or FDA / GMP regulations.
  • Analytical and technical skills.
  • Strong attention to detail.
  • Ability to work independently and in a team environment.
  • Detail oriented, organized and excellent written & verbal skills.
  • Excellent planning, organization, and flexibility to adjust to a rapidly changing environment.
  • Able to lift up to 25lbs.
  • Able to perform Final QC and Receiving Inspection.
  • Certified Lead Auditor.
  • Must be able to travel and work in Burbank and in Valencia.
  • Proficient in ERP program, Microsoft Office Suite, and SmartDraw or equivalent flowcharting program. Strong information technology background.

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