PLEASE NOTE: Must be authorized to work lawfully in the United States for any employer without sponsorship. For immediate consideration, please (1) apply and (2) email your resume directly to: [email protected] .

　　Kelly® Science & Clinical is seeking a Regulatory Affairs Specialist (RAS) for a contract to hire position at a leading client in Valencia, CA. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

　　Pay Rate:

　　$40-55/Hour (commensurate with experience)

　　Overview:

　　This position assists the Director of Quality Operations DQO in maintaining an effective Quality Operations and Regulatory Program, which consistently delivers high quality EZIP 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.

　　Schedule:

　　Monday – Friday, Standard Hours

　　Responsibilities/Qualifications:

　　Essential Duties:

　　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.

　　Internal Audits:

　　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 result.

　　What Happens Next:

　　Once you apply, you’ll proceed to next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.

　　#P1

　　As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

　　Why Kelly ® Science & Clinical?

　　Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

　　About Kelly

　　Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

　　Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center.Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

　　Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.