Regulatory Affairs Coordinator Job Listing at Kelly Services in Irvine, CA (Job ID US3530256_BH9703891)

Description

Join Kelly FSP as a Regulatory Affairs Coordinator on site with our Medical Device client in Irvine, CA! Hybrid Position Tuesday and Thursday in office.

 

Job Description

 

Purpose

Provide support to the Regulatory Affairs department to manage Coordination of training for all Regulatory Affairs (RA) staff globally; Coordinate records maintenance; manage Purchase Orders under budget constraints; lead all administrative duties as requested.

 

Responsibilities.

 

• Responsible for ensuring personal compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance
• Provides administrative support to the RA department as directed.
• Organizes and maintains regulatory compliance documents and databases.
• Maintains database index of regulatory information regarding company products.
• Organizes, maintains and archives electronic and hard copies of submission records, certificates and other regulatory documentation.
• Assist during regulatory and supplier/distributor audits. and maintains audit files.
• Compiles compliance information, provides periodic updates on training requirements and records maintenance to department staff

provides routine and non-routine regulatory reports as requested and keeps regulatory listings current.

• Participates in compliance activities and responds to moderately complex compliance queries.
• Prepares and enters Purchase Orders (for FDA/Notified body fees, check request, Annual Fees, .. ). Works with Regulatory Affairs, Manufacturing, R&D, and other areas to obtain copies of documents for registration.
• Prepares and submits Certificate of Finished Goods (CFG) from FDA CSCATS porthole. Maintain in SharePoint.
• Ordering office supplies and helping with new hire onboardings.
• Perform other duties as assigned.
• Facilitates and maintains department meeting minutes.

 

 

Qualifications

 

Bachelor's degree is preferred

2 years of related experience and/or training in a regulated environment (Regulatory, Clinical or Legal)

Medical Device Regulatory Affairs experience is highly desired.

Strong Attention to details

Being organized

Quality and process improvement oriented,

Must be proficient with MS Office applications

• Excellent communication skills (verbal and written)
• Strong organizational skills
• Project management skills
• Problem solving skills
• Notary is a plus but not required
• Must be on Irvine campus 2 days a week (Tuesday and Thursday)

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 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 participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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