Regulatory Affairs Process Specialist

By | November 8, 2024

Regulatory Affairs Process Specialist

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Job ID: 9627653

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Sunnyvale, CA, US

Scientific

Bachelors Degree

Full Time, Temporary

$47/hour

Experienced (Non-Manager)

On-site

Biotechnology/Pharmaceuticals

First Shift (Day)

Sunnyvale, CA, US

$47/hour

Experienced (Non-Manager)

Full Time, Temporary

Biotechnology/Pharmaceuticals

On-site

Scientific

Bachelors Degree

First Shift (Day)

Apply Now Applied

Job details

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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