Regulatory Affairs Process Specialist Job Listing at Kelly Services in Sunnyvale, CA (Job ID 9627653)

Description

Kelly Science and Clinical is hiring a Regulatory Affairs Process Specialist to work with one of our biotech companies specializing in molecular diagnostics - IVD products 

Pay rate:  $47/hour

Schedule: Day Shift Hours 

Workplace: Remote (preference to someone in US Central or Pacific time zone

Job Description Summary
The Regulatory Affairs Process Specialist will work with the SAP (ERP System) software to maintain accurate regulatory product blocks and releases. They will support maintenance of the database for storing technical dossiers and approval licenses, including but not limited to software validation and data entry

• • The Regulatory Affairs Process Specialist will review change workflows in the Agile PLM system and perform regulatory assessments and notifications as applicable. They will support IVDR launch activities and global expansion projects
    The candidate will have the ability to quickly learn and understand software and database features and functions. They will have knowledge of manufacturing operations and supply chain management, and strong organization skills with the ability to manage multiple responsibilities effectively.

Prior knowledge of different databases like Agile documentation system, Sales Force, and SAP ERP system is preferred

Additional Information

• • Support software tools for organizing regulatory files, registration tracking, documentation for submissions and regulatory blocks/approvals.
  • Basic understanding of technical/scientific principles that relate to multiple, diverse, and or complex product lines or manufacturing processes 
  • Previous experience with SAP ERP system
  • Track regulatory impact for anticipated changes in regulatory database and support team to maintain accurate listing of blocked and released product within the ERP system (SAP).
  • Identify significant changes that would require notification to EU notified body or rest of world health authorities.
  • Update FDA establishment registrations and device listings for IVD products.
  • Maintain and administrate regulatory dossier management system.
  • Assign GMDN and UDI (GTIN) codes to IVD products.
  • Maintain and administrate UDI Management software
  • Understand UDI change management

The essential requirements of the job include:

• • Bachelor's degree in Life Science or related field with 2+ years of related work experience OR Master's degree in field with 1+ years of related work experience
  • Basic understanding of technical/scientific principles that relate to multiple, diverse, and or complex product lines or manufacturing processes either for Med device or IVD products.

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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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