B523
Located in Santa Clarita, CA
Pay: $38.00 - $50.00
Job Full Description
REGULATORY AFFAIRS SPECILIST needed immediately!!! CALL Maria RIGHT AWAY 661-775-2570
If you enjoy being part of a company contributing to saving lives - This might be for you.
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
GENERAL:
- 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.
Quality Management System and Regulatory Affairs Program:
- 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.
Document Control Administration
- 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.
Customer Complaints and Returns (Supports Customer Contact Program)
- 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.
CAPA
- 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.
SKILLS
- Minimum education (or substitute experience) required: Bachelor’s degree in a scientific field
- Minimum experience required: Minimum 5 years of quality assurance, regulatory affairs
- Experience in a medical device environment.
- Experience in pharmaceutical industry and requirements strongly desired.
- Experience with QA systems and Product registrations: FDA, ISO 13485, MDR/MDD, MDSAP
- Knowledge of FDA medical devices and pharmaceutical (drugs) registrations (510k, DMF, NDA, ANDA).
- Knowledge of ISO 14971 and implementation of risk management in medical device and pharmaceutical industry.
- Knowledge of Product Validation desired.
- Self-starter and strong communicator.
- Able to work independently or in a team environment.
- Project management experience and able to manage to timelines.
- Detail oriented, organized and excellent written & 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.
- Excellent planning, organization, and flexibility to adjust to a rapidly changing environment.
- Must be able to travel and work in Burbank and in Valencia.
Qualified applicants with arrest or conviction records will be considered for employment following the law. Including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
Santa Clarita, CA
2868
28159 Avenue Stanford
Suite 110
Santa Clarita, CA 91355
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