Eckert & Ziegler Isotope Products, a subsidiary of Eckert & Ziegler AG, is the world's largest manufacturer of nuclear imaging reference and calibration standards. We are a leading producer of radioactive components for industrial, scientific and medical applications.
We offer comprehensive benefits including 100% employer paid medical and dental coverage for full-time, regular employees, 401(k) matching contribution, generous PTO and paid holidays, tuition reimbursement and a profit sharing program.
We have an opening for a Regulatory Affairs Engineer who will work closely with our Regulatory Affairs Manager to support activities in Valencia and occasionally in Burbank.
General Job Duties:
Quality Management System & Regulatory Affairs Program
Regulatory Licensing and Product Registrations
Document Control Administration – supports electronic document management
Customer Complaints and Returns - supports Customer Contact Program
Manages Internal Audit Program
External Audits of Suppliers and Supplier Qualifications
Supports CAPA Program
Maintains Medical Device Files and Technical Files
Capsule and Package Testing (Back-up)
Receiving Inspection of Components/Returns and Final Quality Control (Back-up)
Travel required at various times to Burbank and for supplier audits and training
Bachelor’s degree in a scientific field
Minimum of five (5) years’ experience in Quality Assurance or Regulatory Affairs
Experience with ISO 9001/ISO 13485, FDA QSR, MDD-CE Mark, CMDR
Experience with medical device product registrations
Excellent communication, verbal, and writing skills. Strong attention to detail.
Excellent computer skills including experience with full MS Office, ERP/MRP systems, Visio or SmartDraw, SharePoint, Document and Configuration Management, Business Process Management workflows, etc.
General PC knowledge with an ability to use statistical, spreadsheet, word processing and graphics presentation software.
Strong written and verbal communication skills with an ability to translate technical information to non-technical users. Must have the ability to read, analyze and interpret general business periodicals, professional journals, technical procedures or governmental regulations.
Strong organization and planning skills. Aptitude with an interest to lead teams and/or individuals with strategic planning and thinking.
Strong analytical capabilities with demonstrated skill in evaluating reports, identifying issues, noting trends, and reporting to management. Must be able to define problems, collect data, establish facts and draw valid conclusions.
Proven ability to learn new technical tools quickly.
Experience handling external and internal audits (Notified Bodies, Regulatory Agencies)
Qualified as an Internal or Lead Auditor.
Ability to work independently and in a team environment.
Excellent planning, organization, and flexibility to adjust to a rapidly changing environment.
Must be able to travel and work in Burbank and Valencia.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
Internal Number: RAE002
About Eckert & Ziegler Isotope Products
Eckert & Ziegler Isotope Products is the business segment providing sealed and unsealed radiation sources for medical imaging, industrial gauging, measurement and analysis, reference, calibration and environmental monitoring sources and solutions as well as bulk radioisotopes for pharmaceutical, therapeutic and industrial product manufacturers.
Our products are manufactured to the highest standards and fully comply with applicable national and international standards. We have some of the industry’s most experienced staff and the broadest product range available, as well as an outstanding record for on-time product delivery. In addition to our standard catalog items, we offer custom and one-off design and manufacturing services.
We have sales staff and offices located in the USA, Germany, France, United Kingdom and Czech Republic and a network of more than 60 international distributors ready to handle your business efficiently and promptly.